- Lilly (Branchburg, NJ)
- …of sterility assurance and applied pharmaceutical microbiology + Understanding of cGMP 's, policies, procedures, and guidelines relating to sterility assurance + ... Demonstrated experience influencing site and network leaders to advance technical agenda projects **Additional Preferences:** + Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing… more
- Berry Global (Monroe Township, NJ)
- …warehouse workers. 4.3.11 Ability to comply with all site PPE and cGMP requirements. **5.0 Organizational Relationship:** 5.1 Reports to the Warehouse Supervisor ... **Contact** **Equal Opportunity Employer/Minorities/Females/Disabled/Veterans/Sexual Orientation/Gender Identity** Amcor is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color,… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …filtration, and potentially formulation/fill-finish operations. + Experience with cGMP manufacturing environments and regulatory requirements (FDA, EMA, ICH). ... + Familiarity with process validation principles and CPV. + Strong analytical, problem-solving, and data interpretation skills (statistical analysis knowledge is a plus). + Excellent communication, collaboration, and influencing skills. + Ability to work… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …techniques, bioreactor operations, and cell line development + Strong knowledge of cGMP regulations and ICH guidelines relevant to upstream biologics manufacturing + ... Experience with a variety of expression systems (eg, CHO, HEK293, microbial) + Familiarity with Quality by Design (QbD) principles and their application to upstream processes + Excellent leadership skills with the ability to mentor and develop team members +… more
- ARUNDEL MACHINE (Emerson, NJ)
- …regulations, prepare submissions and maintain regulatory databases + Adhere strictly to all CGMP , FDA 21 CFR820, ISO 13485, EU MDR and company procedures to ensure ... the quality and integrity of the products and safety of the workplace + Keep Quality area organized and clean + Keep stock of Quality materials such as tip protectors, test materials, etc. + Conduct training on receiving and inspections and orientation for new… more
- AbbVie (Branchburg, NJ)
- …with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent ... must be willing to take temporary assignments as required. Qualifications + Bachelor's Degree required. Life sciences, engineering, or related field preferred. + Three (3) to five (5) years of experience in a laboratory or quality role with preferred… more
- Integra LifeSciences (Plainsboro, NJ)
- …handlers and distribution systems related to manufacturing and utility equipment in a cGMP medical device manufacturing plant. Such equipment may include but is not ... limited to: + Manufacturing Process Equipment (Autoclave Sterilizers, Mills, Mixers, Sealers, Washers) + Facility Equipment (Clean Compressed Air, Heating Hot Water, Clean Steam, Plant Steam, Waste + Treatment, WFI Generation) + Refrigeration Equipment… more
- Kedplasma (Cinnaminson, NJ)
- …Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make your job ... description as complete as possible. However, that in no way states or implies that these duties/responsibilities are the only duties you will be required to perform. The omission of specific duties/responsibilities does not exclude them from the position if… more
- Kedplasma (Cinnaminson, NJ)
- …Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make your job ... description as complete as possible. However, that in no way states or implies that these duties/responsibilities are the only duties you will be required to perform. The omission of specific duties/responsibilities does not exclude them from the position if… more
- Integra LifeSciences (Princeton, NJ)
- …management tools. + Ensure that all projects are in compliance with cGMP , cGLP, QSR (including Design Controls), ISO or other applicable requirements. **DESIRED ... MINIMUM QUALIFICATIONS** The requirements listed below are representative of the knowledge, skill, and/or ability required for this position + Bachelor degree with 8+ years of experience or equivalent education and years of experience + Master degree with 5+… more