A Biotechnology Company is seeking a QA Associate Scientist in Princeton, NJ. Role Description The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the BMS Jump site, including the document change control process, issuance and reconciliation of batch records, batch related forms, product labels, and management of archival and retention of GMP records. Skills & Requirements • Minimum of 1 year of relevant document control management experience in a cGMP/FDA regulated environment • Strong communication and customer service skills. • Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles • Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System) • Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement • Able to prioritize, manage time well, multi-task, and troubleshoot effectively • Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables • Possess project management skills. • Experience interacting with FDA or other regulatory agencies strongly preferred • Strong knowledge of cGMPs and domestic regulatory requirements • Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.) • Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network • Some labeling experience strongly preferred
HAYS PLC • Princeton, U.S.
Job Overview and Responsibilities: Field sampling of various product and process streams. Seek and follow guidance provided by Team Leads, Senior PM’s and Supervisor. Ensure the production of high quality, legally defensible data and reports, safely and on time. Provide excellent customer service. Providing limited or specific technical expertise to our customers. Primary responsibilities include the following (but are not limited to): Conduct basic field sampling projects in conjunction with a more senior technologist.Review field data with assistance from supervisor or more senior field staff to ensure sampling is completed as per applicable test methods and protocols.Prepare equipment and chemicals, client confirmation and site-specific safety training, field sampling, field QA/QC of data, collection of field data, fill out daily WHA forms and daily field reports, turns over completed data to senior technologist on project in a timely manner.Perform equipment maintenance, repair and calibration at direction of Supervisor or senior field staff, with training from Senior Project Managers.Provide excellent customer service by always presenting a professional attitude and representing Bureau Veritas in a positive way; comply with all client and Bureau Veritas safety initiatives and rules; provides technical support and expertise to our clients; ensure that all Client requests and expectations are met.Ensure vehicle fleet is maintained in clean, working order and Bays are kept clean at all times.Perform QA/QC of data as required by Reporting or Management.Ensure daily use of personal monitors, gas monitors during field projects, and use of all required PPE.Support and comply with all Bureau Veritas policies, Quality System and Health & Safety program.Participate, when requested in lab and Health & Safety meetings and internal and external audits.Provide general lab support to other departments as required.All other responsibilities as assigned. Is there a mutual fit? You ideally have: 2-year technical diploma or 2-3 years relevant chemistry related or relevant work experience.Basic understanding of well and plant processing techniques and concepts.Basic knowledge of sampling methods and theories.Basic understanding of chemistry, plumbing, and electrical techniques and concepts.Willingness to travel and work extended hours in the field.Knowledge of safe work procedures and requirements.Good driving record with less than 6 demerits and meets federal carrier driver requirements. Schedule:Monday to Friday May require flexible workings hours and overtimeEvenings, week-ends and out of town travel may be required
Receptix • Edmonton, Canada
Seeking Entry Level candidates with a Bachelor's Degree in Biology, Chemistry, Microbiology, Biochemistry, or other scientific field, to work as QA Analyst / Consultants for a pharmaceutical client in Fort Worth, TX 76134. Recent graduates are fine.Technical Accountabilities:- Audit product lots- Pull analytical samples- Pull, log and inspect retention samples- Review MBR for release- Review and approve autoclave reports and logbooks- Update databasesEducation/Experience:- B.S. in Science (Chemistry, Biochemistry, Biology, Microbiology, Pharmacy) Demonstrated excellent written/verbal/interpersonal/communication and ability to perform effectively in a fast paced, team oriented environment. Skills:- Good computer skills- Good time management & communication skills- Attention to detail- Ability to multi-task- Fluent in English
Careerbuilder • Fort Worth, U.S.
Who are you and what will you do?You are the technically capable and passionate leader of our Propulsion Systems Integration team based in Greensboro, NC. While guiding the PSI team, you will report directly to the North American Powertrain Engineering Vice President in Hagerstown, MD. With your excellent networking skills, you will represent Powertrain Engineering in a variety of local and global teams within which you will coordinate activities, process development/execution, and competence development.You will directly lead a section of engineers to integrate propulsion systems into vehicles that meet customer requirements, regulatory, and Volvo Group objectives. Integration includes packaging, electrical, mechanical, and all other aspects required to integrate propulsion systems into vehicles. You will contribute to the Volvo Group’s competitive market position by assuring the development and maintenance of products and product components that out-perform the competition in quality, delivery, cost, and function, while ensuring they comply with all applicable regulatory requirements.You will showcase your abilities to negotiate and manage relationships as the Director responsible for vendor engines for North American applications, regulatory compliance, and Validation and Verification of North American Powertrain products. The validation and verification of these products must stay aligned with commitments to projects and other defined customers, and will remain consistent with corporate strategy, global processes, standards, and regulations.You will demonstrate both your organizational and people leadership skills by being responsible for planning, budgeting, and Human Resources functions in the section, e.g., securing resources, competence and professional development, and talent management for all employees. (Our People & Culture team are looking forward to partnering with you!)Responsibilities and authorityResponsibilitiesRepresent Powertrain Engineering (PE) on site at the satellite office located in Greensboro, NC.Represent Powertrain Engineering in the North American Vehicle Product Decision Committee.Product development and maintenance for the Cummins North American engine platform (9L – 15L engines) and drivelines with regards to quality, cost improvement, follow-up, and Product Modification Requests.Regulatory documentation compliance coordinated with Cummins for Cummins OEM installed powertrain products in North America.Responsible for all first estimates for PE Product Modification Requests in North America.Represent Powertrain Engineering in all customer adaptation activities for North American products.Responsible for Continuous Improvement activities for the section, coordinated with global and regional program leaders including Operational Development.Responsible for ensuring use of relevant processes and methods.Responsible for developing and maintaining appropriate cross functional network with the counterparts at other Powertrain Engineering sites, Vehicle Engineering sites and with other functions.Responsible for planning, budgeting, and follow-up of all section activities.Breakdown and follow up of targets from the Site VP and from global leaders including development, reporting and improvement of Key Process Indicators for the section.Responsible for ensuring coordination across projects and divisions.Responsible for Human Resources functions in the section, e.g., securing resources, competence and professional development, and talent management for all employees (e.g., Personal Business Plan).Perform administrative reporting (e.g., costs, investments, and employment changes).Frequent travel to the Hagerstown, MD (Main PE office) is required.International travel may be required from time-to-time.AuthoritiesApprove deliveries according to relevant processes and authorizationsApprove purchases of materials and services consistent with the position’s authority levelApprove travel plans and expense reports for your sectionApprove time reporting for your direct reportsApprove personnel requisitions issued in your sectionMake relevant HR decisions with the support of our People & Culture teamWhat are we looking for?BS in Engineering (required). Advanced technical or business degree preferred.10+ years of relevant experienceSuccessful experience in Group or Project managementStructured, analytical, and holistic mind-setProject/Team leading experienceStrong oral and written communication skills in EnglishGood knowledge of systems engineering, quality assurance methods and documentationCompassionate and willing to mentor and grow your team
VolvoAuto Sweden Sa • Greensboro, U.S.
NMC Royal Hospital KLFJob Summary:Assist the Laboratory Supervisor in the coordination of laboratory activities. Provide accurate, timely and cost effective testing of patient samples to aid in the diagnosis and treatment of disease in compliance and harmony with the quality management system. The Lab Technician has supervisory responsibility, limited to his / her work departmentMedical technologist may be rotated through the various laboratory departments in order to keep himself / herself familiarized with those laboratory procedures which may be ordered on an emergency basis when working shifts.Duties & Responsibilities:Technical:Lab Procedures: Performs a variety of technical laboratory procedures according to Medical Center, laboratory and national standards to obtain patient specimens using to ensure specimen quality used to aid in the diagnosis and treatment of disease. Responsible for performing and observing hematological, biochemical, serological and specially requested tests on patients specimens and correctly records all results.Administrative:Documentation: Responsible for accurately completing records and reports and other statistical information for master files or databases. Follows laboratory policy for data retrieval, record keeping, specimen, and identification, requisition, reporting, charting, and billing procedures. Updates Records and Documents on a daily basisCommunication/Teamwork: Maintains positive working relationship with the medical staff and hospital personnel. Uses positive interpersonal skills to educate/support lab customers and promote success of team members. Uses clear and concise verbal and written communication with staff and the public. Acts independently on supervisor’s direction and accepts responsibility of the adopted policy and procedures of the hospital and the laboratory. Shares call duty and works different shifts as required. Immediately notifies the patient care unit or physician of any critical test results, within 20 mints of the result generation. Interacts professionally with all department members, physicians’ staff, administration and the Administrator of Clinical Laboratory and Pathology. Quality Control/Quality Improvement: To perform and follow quality assurance programs for various laboratory sub departments. Participates in Internal and external QC/QI for area of specialty and Lab indicators. Does not report patient results unless quality control data are within accepted parameters. Recognizes out of control values, takes corrective action, and notifies others of changes to the laboratory supervisor.Safety & Education: Complies with laboratory safety procedures. Possesses adequate knowledge of instrumentation, theory, and application of new and existing tests. Completes education necessary to maintain licensure or certification for the job. Uses and maintains all laboratory equipment correctly. Problem Solving/Critical Thinking: Assumes responsibility to resolve problems. Performs required preventative maintenance procedures in laboratory instrumentation. Investigates and resolves technical problems, consults supervisor if resolution involves policy or procedure modification. Identifies real or potential situations or equipment failure, attempts to resolve within area of specialty or knowledge and refers complex issues to appropriate source. May be a key analyzer operator with proper training and documentation of skills.Follows the laboratory safety policies and participates in safety education programs. To attend and follow continuous medical training and education program.Comply with all OSH and infection control policies, standards and procedures and cooperate with hospital management to comply those requirementsWork accordance with the documented OSH procedures and instructions, specific responsibilitiesBe familiar with emergency and evacuation proceduresNotifying OSH Hazards, incidents, Near misses and issues and assistance with the preparation of risk assessments, incident reportsComply with Waste management procedures and policiesAttend applicable OSH/Infection control training programs, mock drills and awareness programsUse of appropriate personal protective equipment and safety systemsTraining: Attends departmental and organizational training as when required to keep him/ herself updated on the laboratory policies and SOPs.Qualifications Qualification, Licensure, Education, Experience, Special Skills:Associate Degree in Medical Laboratory TechnologyAt least two (2) years of Medical Laboratory experience.Currently licensed in country of origin and with HAAD license to practice in Abu-Dubai UAE.Fluent in spoken & written English, Arabic language is desirable, but not essential.Primary Location: Royal Hospital - Khalifa City - Abudhabi Work Locations: Royal Hospital - Khalifa City - Abudhabi Abu Dhabi Abu Dhabi Job: Medical Organization: NMC Royal Hospital KLFFull-time
Alliance Employment Services • Abu Dhabi, United Arab Emirates
LabCorp is seeking a Clinical Laboratory Supervisor to join our team in Charlotte, NC. In this position, you will work in a fast paced, customer focused, and challenging environment, and will be a part of our overall mission at LabCorp: "Improving Health, Improving Lives" as we combat the COVID-19 pandemic.Job Duties/ResponsibilitiesSupervise the day to day operations of the laboratoryEnsure laboratory tests are accurately performed and results are reported in a timely mannerDirectly supervise, train, and mentor laboratory personnel of the departmentMonitor daily workflow in the lab and schedule adequate assay coverageResponsible for ensuring all shifts in the department are properly staffedResearch and resolve any production errors while escalating when necessaryEngage in continuous process and service level improvementsEnsure all equipment is being properly maintained through Quality ControlPrepare and maintain Quality Assurance records and documentsEvaluate new process improvements and make appropriate recommendationsMeet regularly with direct reports to provide coaching and feedback for their developmentPerform bench work as needed and maintain proficiency/competency in technical operationsEnsure all work is in accordance with state and Federal regulationsResponsible for administering and managing policies and proceduresProcess and maintain payroll and personnel filesPerform administrative duties as neededBachelor's degree in Medical Technology or a Science related majorMinimum 2 years of experience as a Medical Technologist in a clinical laboratoryPrior experience in Chemistry, Hematology and Urinalysis is highly preferredPrevious supervisor experience is preferredASCP and/or AMT Certifications are a plusStrong working knowledge of CLIA, CAP and relevant state regulationsUnderstanding of laboratory operations as well as policies and proceduresProficient with Laboratory Information Systems and Microsoft OfficeStrong communication skills; both written and verbalHigh level of attention to detail with strong organizational skillsComfortability making decisions in a changing environmentAbility to handle the physical requirements of the position
Careerbuilder • Charlotte, U.S.
What you'll do...Provides pharmaceutical care to Customers, including processing and accurately dispensing prescription orders, counseling Customers regarding health care and prescription medication needs, maintaining confidential information, maintaining controlled medication and required documentation.Models, enforces, and provides direction and guidance to Associates on proper Customer service approaches and techniques to ensure Customer needs, complaints, and issues are successfully resolved within Company guidelines and standards.Ensures compliance with Company and legal policies, procedures, and regulations for assigned areas by analyzing and interpreting reports, implementing and monitoring loss prevention and safety controls, overseeing safety, operational, and quality assurance reviews, developing and implementing action plans, and providing direction and guidance on executing Company programs and strategic initiatives.Maintains confidential information, documentation, and assigned records as required by Company policies, and local, State, and Federal guidelines.Provides comprehensive patient care to customers by processing and accurately dispensing prescription orders; administering immunizations; counseling customers regarding health care and prescription medication needs; and maintaining confidential information, controlled medications and required documentation.Demonstrates up-to-date expertise and applies this to the development, execution, and improvement of action plans by providing expert advice and guidance to others in the application of information and best practices; supporting and aligning efforts to meet customer and business needs; and building commitment for perspectives and rationales.Provides and supports the implementation of business solutions by building relationships and partnerships with key stakeholders; identifying business needs; determining and carrying out necessary processes and practices; monitoring progress and results; recognizing and capitalizing on improvement opportunities; and adapting to competing demands, organizational changes, and new responsibilities.Models compliance with company policies and procedures and supports company standards of ethics and integrity by incorporating these into the development and implementation of business plans; using the Open Door Policy; and demonstrating and assisting others with how to apply these in executing business processes and practices.Minimum Qualifications:Bachelor's Degree in Pharmacy or PharmD degree, or equivalent FPGE (NABP). Pharmacy license (by job entry date). Completion of an ACPE Accredited Immunization training program (for example, APhA, Pharmacy School Curriculum, State Pharmacy Association sponsored).
Walmart • Washington, U.S.
Currently, we have several roles available depending on your knowledge and skill set including:� Oven Operator� Mixer Operator� Packaging Line Operator Summary:Reporting to the production supervisor, line operator will follow good manufacturing practices (GMP�s) and food safety standards by operating different types of equipment. The incumbent will prepare for the production line start-up, ordering the proper ingredients and materials to be used, check the quality of the product, and report any concerns that need to be addressed. Job responsibilities:� Safely operate assigned line equipment in accordance with the standards and specifications associated with each production area following all proper sops. This includes but is not limited to the mixer; make up line, proofer/retarder(s), oven and packaging. � operate the specific equipment efficiently and ensures product standards, specifications, and quality requirements are met� ensure ingredients and other raw material are stored safely and check for any cross-contamination� use and dispose of cleaning agents and chemicals in a safe and efficient manner� troubleshoot issues under pressure and perform root cause analysis with corrective actions to prevent the same issues in future� Participate in operator-based machine maintenance� practices and complies with all company policies and procedures including health & safety, work rules, etc.� performs other job-related duties as requiredQualifications and Requirements� high school diploma or equivalent combination of education and experience� prior experience or training in manufacturing environment is preferred� ability to operate and work with mechanical and electrical machines� ability to understand and follow both written and verbal instructions, warnings, labels, and postings in English effectively and with a high level of detail� ability to work and communicate effectively in a fast-paced environment � ability to learn and abide by the gmp-s and health & safety standards� computer literacy Work and Physical requirements� ability to lift, pull, and push up to 50 lbs� ability to stand or walk for prolonged periods of time� perform repetitive motions, and work in an environment with varying temperatures� willing to work in shifts from Monday to Friday and Saturdays (subject to orders)� Overtime may be needed Shift available: � morning (7am to 3pm), � afternoon (3pm to 11pm), � night (11pm to 7am)
Alliance Employment Services • Toronto, Canada
Location Ajman Saray a Luxury Collection Resort Ajman, Sheikh Humaid Bin Rashid Al Nuaimi Street, Ajman, United Arab Emirates, United Arab Emirates Brand The Luxury CollectionSchedule Full-TimeThe Luxury Collection is a glittering ensemble of locally authentic hotels and resorts from around the world. Our hotel teams curate the world's most enriching and desirable destination experiences. Our mission is to guide our guests, these seasoned travelers on transformative journeys that touch their spirits, enrich their lives and create lasting memories. If you are someone with an appreciation for evocative storytelling and a desire to provide genuine, personalized, and anticipatory service, then we invite you to join us on our journey and explore a career with The Luxury Collection.POSITION SUMMARYSchedule services for individuals and large groups using spa/salon reservations software system. Call guests to confirm scheduled services. Answer questions about available services. Update the reservations/cancellations list throughout the day, inform providers of last-minute changes, and resolve scheduling issues as needed by working with supervisor/manager. Check in guests for appointments, confirm first and last name, and provide general spa orientation to guests upon arrival. Promote and sell spa/salon services. Obtain assigned bank and ensure accuracy of contracted monies, obtain change required for expected business level, and keep bank secure at all times. Process guest payments for spa/salon services and obtain payment authorization as needed. Accept and log cash tips for employees. Balance, scan, and drop receipts with Accounting. Notify Engineering of maintenance and repair needs.Report accidents, injuries, and unsafe work conditions to manager. Follow all company policies and procedures; ensure uniform and personal appearance are clean and professional; maintain confidentiality of proprietary information; protect company assets. Welcome and acknowledge all guests according to company standards; anticipate and address guests' service needs; assist individuals with disabilities; thank guests with genuine appreciation. Speak with others using clear and professional language; answer telephones using appropriate etiquette. Develop and maintain positive working relationships with others. Comply with quality assurance expectations and standards. Stand, sit, or walk for an extended period of time. Move, lift, carry, push, pull, and place objects weighing less than or equal to 10 pounds without assistance. Perform other reasonable job duties as requested by Supervisors.Marriott International is an equal opportunity employer.
Caterer Global LTD • Dubai, United Arab Emirates
QA Specialist – Contract or CTP – Morris Plains, NJRole DescriptionThe Quality Assurance delivers on the client's commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies. As part of the broader Pharmaceutical Development & Manufacturing (PDM) team you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. The Quality Assurance on the floor is responsible for coordinating, managing on the floor Quality Oversight within commercial Drug Product operations to ensure sustained compliance with GMPs and regulatory readiness. • Provides Quality oversight to operations on the shop floor. Supports manufacturing operations (upstream and downstream) at real time. • Assists and advises on pertinent quality issues as they arise during plant operations. • Troubleshoot and elevate noncompliance issues and events observed. • Demonstrates knowledge of investigation, CAPA, and corrective action processes. • Demonstrates ability to effectively prioritize and manage multiple project workloads • Ensures compliance to policies and procedures • Maintains and supports material inventory, status and transfers. • Performs and supports changeovers in production area as required. • Participates in audits and other projects as appropriate. • Supports manufacturing operations (upstream and downstream) and staff as needed to identify and address product quality and compliance issues as they arise. • Reviews documentation associated with production operations. Ensures adequate levels of documentation are acceptable and compliant to existing procedures. • Participates in process improvement initiatives targeting for Right First Time (RFT) on documentation. • Participates in activities associated with event resolution and CAPAs, with a focus on organizing and attending cross-functional meetings. • Implements and ensures adherence of appropriate regulations and quality standards. • Supports operations to encourage a Quality Culture and ensure a safe working environment. • Completes job-related training as required. Skills & Requirements • 2+ years of relevant experience in a GMP environment related field and a BS OR 3+ years of relevant experience and an AA degree. • Prior experience in pharmaceutical industry is preferred.
HAYS PLC • Morris Plains, U.S.
The Building People, LLC, has a position open for a full-time senior level Drafter/CAD Specialist III in support of a Federal client. Responsibilities · Design and draft CAD detailed design drawings to support furniture reconfiguration and space layout projects · Document requirements and provide associated drawings that meet customer specifications. · Adjust current drawings and recommend changes based on their understanding and knowledge of the project · Follow project schedules and meet project due dates · Work closely with facilities and space management client, facility occupants (customers), and furniture installers to make sure that the design and installation is precise and done according to specification. · Perform building site surveys to verify as-built conditions to include; existing furniture, light switches, receptacles, fire strobes, HVAC equipment and any wall mounted equipment. · Collect, review and interpret customer specifications · Create current/proposed AutoCAD layout based on customer requirements for furniture renovation projects with build/demo instructions to include part list. Submit PDF build package to installation team and schedule via shared build calendar. · Interpret specifications where needed · Aid in increasing and maintaining quality assurance processes for layout creation. · Coordinate filing, storage, and retrieval of both manual and electronic drawings · Utilize project management techniques from design process through final furniture installation · Demonstrate ownership of final Space Management projects · Exercise superior written and verbal communication skills Required Experience & EducationA minimum of three (3) years of experience drafting/illustrating in the furniture field to include computerized drafting applications, digital imaging techniques.Familiarity with and understanding of engineering concepts and terminology is important.Working knowledge of CAD standards, PC application software and drafting/engineering practices and methods.Knowledge of Adobe Acrobat, current version of Auto CAD, Excel and MS Office is required.Ability to work in a dynamic environment and adapt to frequent project changes.Ability to follow complex instructions and diagrams to create or modify drawings using company and government drafting standards.Accuracy and effectiveness in electronic drafting.Ability to work effectively as part of a team or independently with minimal oversight.Ability to obtain a DOD security clearance and work in a secure environment.A minimum of a high school diploma (HSD) or equivalent is required for this position.
The Building People • Charleston, U.S.
Vos Missions :• Rédiger et exécuter des protocoles d’essais en respectant les standards internes. • Définir et participer aux étapes d’industrialisation et / ou amelioration de procedés de fabrication • Définir la stratégie et exécuter les validations initiales des nouveaux procédés et équipements complexes • Participer au transfert technologique des procédés de fabrication définis et communiqués par les équipes Développement et projets, • Créer ou mettre à jour la documentation projet ou du système du SMQ dans le cadre de son activité en conformités avec les standards internes. • Soutenir les activités de production en prodiguant une expertise pour la résolution de difficultés process Proposer, harmoniser et implémenter les méthodes de travail en vue de cette amélioration • Participer et/ou animer le processus d’analyse de risque, • Participer si nécessaire au processus de déviation, investigation et CAPA • Participation aux validations ou revues périodiques, • Réaliser un reporting régulier de son activité, • Veiller au respect du système Qualité en vigueur, des bonnes pratiques de fabrication, des règles d’hygiène et de sécurité, des règles de fonctionnement de l’entreprise. • Préparer la documentation technique nécessaire pour soutenir un examen des autorités compétentes concernées, en accord avec les normes applicables en vigueurQualifications & Experience• Diplôme d’ingénieur ou équivalent, • Expérience d’au moins 2 ans en R&D ou en Engineering, idéalement acquise dans le domaine de la chimie des polymères, des dispositifs médicaux. en qualification / validation • Connaissances de la norme ISO13485, des BPF et autres normes applicables au dispositif médicaux • Maîtrise des outils informatiques de bureautique standards • Français et anglais courant • Expérience projet en tant qu’acteur ou gestionnaire ayant permis de démontrer une aisance relationnelle, des capacités à dialoguer avec des interlocuteurs variés internes et externes à l’entreprise
Approach People Recruitment • Lausanne, Switzerland
Nom de famille