- ThermoFisher Scientific (Bridgewater, NJ)
- …business growth. + Ensure compliance to quality system requirements (eg DEA, ISO 9001, cGMP ) to meet the requirements of our customers for our products. + Drive ... continuous improvement activities and projects to move the organization towards a proactive quality approach. + Leverage key quality business metrics that align with customer expectations to drive year-over-year improvement, enabling business growth. + Support… more
- Bristol Myers Squibb (Summit, NJ)
- …of Cell Therapy products according to Current Good Manufacturing Practices ( cGMP 's) following the current, approved Standard Operating Procedures (SOPs) and Work ... Instructions (WIs). + Responsible to own, review, author, or approve SOP, WI, master batch records. + Responsible for setting strategic direction for the WCT while maintaining or exceeding compliance, budgetary, safety, and technical requirements. + Has direct… more
- Bristol Myers Squibb (Summit, NJ)
- …and Warren NJ sites if needed. **Knowledge & Skills:** + Knowledge of cGMP /FDA regulated industry + Basic mathematical skills + General understanding of cGMPs + ... Technical writing capability + Proficient in MS Office applications + Inventory control and/or management + Background to include an understanding of biology, chemistry, medical or clinical practices is a plus **Basic Requirements:** + Bachelor's degree + OR… more
- Merck (Rahway, NJ)
- …+ Demonstrated success in applying modeling outcomes in commercial and cGMP environments. + Familiarity with regulatory filings (BLAs, NDAs) and Chemistry, ... Manufacturing, and Controls (CMC) processes. + Experience with high-performance computing. + Strong publication, presentation, or patent record. + Knowledge of statistical software (Minitab, JMP) and other related modeling techniques such as machine learning… more
- Lilly (Branchburg, NJ)
- …Life Sciences industry, maintaiing excellent working knowledge of pharmaceutical regulations (eg cGMP 's, 21 CFR Part 11, Computers Systems FDA) and other applicable ... regulations (eg Privacy, OSHA, etc.) related to laboratory and/or manufacturing environment and system applications. **Additional Skills/Preferences:** + MS/MBA desirable. + Ability to work on multiple concurrent project initiatives. + Experience with managing… more
- Berry Global (Monroe Township, NJ)
- …immediately. Reports accidents to the supervisor immediately. Follows site cGMP and Safety requirements. Performs other duties as assigned. **Qualifications** ... **Qualifications:** **Skills** Must have the ability to remember packing sequence and pack patterns. Ability to carry out work orders, make decisions on bottle jams. Must be able to meet deadlines. **Education and/or Equivalent Experience** Basic math skills.… more
- BD (Becton, Dickinson and Company) (Branchburg, NJ)
- …years of people leadership experience + Prior experience in a regulated ( cGMP , ISO) environment + **Technical Skills:** + Strong background in combination product ... or medical device testing + Knowledge of method development, validation, and regulatory compliance + Deep understanding of drug-device development, design control, and system integration + **Leadership Skills:** + Proven experience in operations leadership +… more
- Sokol Materials & Services (Skillman, NJ)
- …device analytical testing ishighly desirable. + Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5. + Knowledge of electronic systems ... including any of the following: SAP, LIMS, TrackWise,Veeva Vault and electronic, or paper-based batch records desirable. + Excellent Technical writing and oral communication skills are required. + Background in problem solving + Knowledge of Data integrity… more
- Teva Pharmaceuticals (Edison, NJ)
- …Knowledge, Licenses, Certifications: + Knowledge of Current Good Manufacturing Practices ( cGMP ), Food and Drug Administration (FDA), OSHA and related federal, state ... and local laws, codes, regulations and regulatory requirements + Knowledge of pharmaceutical manufacturing operations to support the approval of protocols, reports, procedures and specifications. + Strong Understanding of Process Controls and Systems… more
- WuXi AppTec (Cranbury, NJ)
- …and implement SOPs + Review and maintain research notebooks in accordance with cGMP , GLP, and EPA and FDA regulations **Qualifications** Requires a Master's degree ... in Biological Sciences, Biochemistry, or Materials Science and Instrumentation plus skills and knowledge in SOPs, Cell harvesting, dosing and cell incubation, Solid Phase Extraction (SPE). Job location: Cranbury, NJ. Standard company benefits with… more