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Proficiency with the use of global systems (e.g., Systems, Applications and Products (SAP), Document Control and Archiving (DCA. Represent Quality on cross-functional teams within the "Virtual Manufacturing Plant", Technical Transfer teams, Supplier Selection, Serialization Manufacturing and Packaging launch teams.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Manages CMO relationships from a quality and compliance perspective, including monitoring quality metrics, performing annual risk assessment of CMOs and executing oversight as defined by Standard Operating Procedures (SOP’s), authoring and executing Risk Mitigation Plans as needed.
ExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Innova Solutions offers benefits (based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time.
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Study close-out experience, including: international device shipping (returns), archiving, risk mitigation, and management of decommissioning activities with eCOA vendor. Solid study start-up experience, including having led cross-functional kickoff meetings for EDC, ePRO and/or eCOA activities.
ExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Represent Bristol Myers Squibb during FDA/other regulatory inspections and corporate GMP compliance audits as defined in related Quality Agreements. Five years pharmaceutical experience with batch record review, deviation and change control oversight experience.
$45 - $46 an hourExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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A minimum of five (5) years' experience in pharmaceutical, biologics, biotech or related industry with relevant experience. B.S. in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy or equivalent.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Assist the team with the preparation, handling, distribution, filing, and archiving of documentation and reports according to standard operating procedures. eQMS experience (Master Control preferred.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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We believe in providing staffing solutions to address the current talent gap Right Talent Right Time Right Place Right Price and acting as a Career Coach to our consultants. Investigate and/or evaluate manufacturing, packaging and laboratory deviations or incidents and associated Corrective and Preventive Actions (CAPA's) and provide direction and recommendations as to future course(s) of action.
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Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Batch record review, deviation and change control oversight experience. experience in pharmaceutical, biologics, biotech or related industry with relevant experience with. Manages CMO relationships from a quality and compliance perspective, including monitoring quality metrics, performing annual risk assessment of CMOs.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Our client, a leading pharmaceutical company, is hiring a Quality Manager on a contract basis. Experience in the manufacture of drug substance and/or drug product or quality control laboratories is desired Biopharma Behaviors.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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5 years experience in pharmaceutical, biologics, biotech or related industry with relevant experience. Knowledge in solid dosage forms, parenteral technology, biologics or combination products. Knowledge of compendial and cGMP requirements, FDA regulations and the ability to interpret and apply them.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Assists in project close-out procedures for all projects including: arranging archiving of hard copy files; receipts of necessary close out/turnover documents; compliance with close-out checklist; coordination of lien searches; receipt of occupancy and closed building permits and warranty manuals; receipt of As built and CAD drawings for submission to CAFM; and, collection of required documents for project audit.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Participate in audits (For Cause) of North American External Manufacturers of drug products ensuring compliance with all appropriate Client and FDA and European Medicines Agency (EMA) cGMP regulations and policies.
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Coordinates record archiving and destruction. Coordinates record archiving and destruction. Maintains active medical records and organizes thinned records for safekeeping. Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.
Full-timeExpandApply NowActive JobUpdated 2 days ago
archiving job in Woodbridge, NJ
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