- Merck (Rahway, NJ)
- …(FLEx) Center to support drug product development and good manufacturing practice ( GMP ) clinical supply of sterile dosage forms. Positions will support development ... feedback on product and process development. These roles require adherence to GMP procedures, strong attention to detail in completing GMP documentation,… more
- Innovation Foods LLC (Millville, NJ)
- …standards. Oversee and monitor all quality programs (FSMA, HACCP, SQF, GMP , Positive Release, Pest Control, sanitation, in-line sampling, allergens, gluten-free and ... programs; process specifications and standards; sanitation programs, HACCP and GMP programs; production labeling; and product storage and distribution. Oversee… more
- Actalent (Princeton, NJ)
- …routine lab operations to ensure product and facility compliance with GMP standards. Responsibilities + Perform environmental monitoring (EM) of cleanrooms, ... sciences field. + 1 year of experience in a GMP -regulated QC microbiology lab, preferably in cell therapy, biologics,...Knowledge of regulatory guidelines (USP <61>, <62>, <85>, <1116>, FDA , EU). + Bachelor's degree in a relevant scientific… more
- Promotion In Motion (Somerset, NJ)
- …food safety and quality issues to Plant management and SQFP + Follow PIM Brands GMP rules + Monitor fellow employees for adherence to GMPs. + Ability to work ... workstations. + Approve or reject reworked items. + Conduct GMP inspections to ensure compliance. + Monitor, verify and...Certificate of Analysis is provided by the Supplier and FDA documents have been released for imported products. +… more
- Actalent (Basking Ridge, NJ)
- …on business requirements. Essential Skills + Quality assurance expertise. + Knowledge of FDA regulations. + Understanding of SOPs. + Ability to partner with members ... like Regulatory and Quality to ensure compliance. + Proficient knowledge of GMP and Quality Management Systems. + Computer literacy in Windows applications and… more
- Integra LifeSciences (Plainsboro, NJ)
- …ISO 7 and ISO 5 Clean Rooms and with Good Manufacturing Practices ( GMP ), Quality Systems Regulations, Standard Operating Procedures (SOP's), and Health and Safety ... costs, quality, and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. +...+ 3+ years of relevant leadership experience in a GMP regulated industry. + Knowledge of NCs and CAPAs.… more
- Integra LifeSciences (Plainsboro, NJ)
- …Compliance** will have an in-depth understanding and knowledge of appropriate GMP compliance and other applicable national and international regulations, laws, and ... auditor), and provide follow-up for internal audits and/or assessments of all GMP /GLP related site activities. + Assembly and coordination of the audit team,… more
- Integra LifeSciences (Plainsboro, NJ)
- …compliance with ISO 7 Clean Rooms and with Good Manufacturing Practices ( GMP ), Quality Systems Regulations, Standard Operating Procedures (SOP's), and Health and ... costs, quality, and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. +...+ 3+ years of relevant leadership experience in a GMP regulated industry. + Knowledge of NCs and CAPAs.… more
- J&J Family of Companies (Raritan, NJ)
- …+ A minimum of 6 years of relevant business experience in a GMP -regulated industry, inclusive of regulatory compliance experience is required. + Knowledge of cGMP ... regulations and FDA /EU Guidance related to the manufacture of biologics or...Experience or Certification performing internal or external audits of GMP regulated facilities is preferred (ASQ or equivalent). +… more
- Integra LifeSciences (Plainsboro, NJ)
- …Ensure compliance with all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, CMDR and the Medical Device Directive. ... samples for shipment to third party labs when necessary + Maintain GMP /GLP laboratory notebooks and documentation relevant to the duties and responsibilities… more