- SOFIE (Totowa, NJ)
- …for regular production of radiopharmaceuticals for preclinical or clinical use according to cGMP standards. o It is expected that the development of these protocols ... and maintenance instructions, and procedure manuals required. Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification… more
- SOFIE (Totowa, NJ)
- …and maintenance instructions, and procedure manuals required. Knowledge of cGMP requirements, aseptic process (cleanrooms environment), and equipment qualification ... preferred. Efficient in the use of MS Office Suite required. Ability to be detail-oriented, accountable, patient, and work in a team environment with minimum supervision required. Individual must be capable of learning and understanding multiple disciplines.… more
- Slipstream IT, LLC (Trenton, NJ)
- …11: Computerized Systems. FDA Guidance on Data Integrity and Compliance With CGMP . FDA Draft Guidance on Computer Software Assurance (CSA). Good Manufacturing ... Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP). ICH E6 (R2) Good Clinical Practice Guideline. Key Duties & Responsibilities Strategic Leadership: Develop and implement a global CSV and CSA strategy. Ensure alignment of CSV… more
- Taiho Oncology in (Princeton, NJ)
- …and manufacturing. Strong working knowledge of current Good Manufacturing Practices ( cGMP ). Detail orientation, with emphasis on accuracy and completeness. Excellent ... written and oral communication. Ability to reason, persuade and negotiate with regulatory authorities. Good organizational and planning skills; drive for results. Good interpersonal skills that involve working well in a team environment and the ability to lead… more
- MSD Malaysia (Rahway, NJ)
- …knowledge. Strong knowledge of relevant cGMPs, US and European cGMP guidelines, ICH, and other international regulatory requirements.Excellent communication, ... decision-making, people influencing, and project management skills. Strong problem-solving and critical thinking skills with the ability to identify potential compliance issues.Nice-to-have skills or qualifications include first-hand experience with multiple… more
- Barry-Wehmiller Companies Inc. (East Brunswick, NJ)
- …and Fault Tree Analysis (preferred) An understanding of good documentation practices, cGMP , and FDA validation methods and systems A working knowledge of process ... automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 compliance, and the latest industry expectations for data integrity Strong project management software and word processing skills, and solid technical writing skills A… more
- MSD Malaysia (Rahway, NJ)
- …new products, and maintaining the automation systems in compliance with cGMP * Lead automation related investigations into deviations and implement the corrective ... actions* Working with external companies, organizing spare parts and service visits* Serve as a technical mentor and help train rotational and new employees, and supervise staff performing GMP activities and deliver training as needed**Required Education,… more
- Hispanic Alliance for Career Enhancement (Rahway, NJ)
- …of vaccines/biologics, medical devices). Strong compliance mindset and understanding of cGMP , including FDA and EMEA. Demonstrated strong project leadership of ... cross‑functional teams through project planning, execution, monitoring and closeout phases to deliver successful completion to project target milestone dates. Ability to work effectively across boundaries to build strong collaborative relations with other… more
- MSD Malaysia (Rahway, NJ)
- …product/medical device and healthcare regulations, including FDA combination products cGMP , Quality System Regulation, FDA Human Factors guidance, ISO 14971, ... EN 62366, Council Directive 93/42/EEC, etc.* Self-motivated with the ability to work independently.* Experience with FMEA, statistical sampling, and control strategy.* Proven ability to work with team members of diverse skill sets and backgrounds.* Strong… more
- BeOne Medicines (Pennington, NJ)
- …facility and then shift focus to hands-on execution and support of cGMP manufacturing operations. **Facility Start-Up** : Focused on related activities required to ... execution + Acceptance testing and equipment/automation debugging + Technical training **Hands-On cGMP Operations** : Focused on execution of cGMP manufacturing… more
