Sr. Manager, Quality Operations
The Contractor for Quality Operations, supports quality operations related to GMP compliance for Clinical and Commercial products.
The incumbent works cross-functionally with internal departments and external resources on quality assurance related issues.
The incumbent supports adherence to relevant regulatory requirements and company SOPs, as appropriate.
location: South Plainfield, New Jersey
job type: Contract
salary: $60 - 65 per hour
work hours: 9 to 5
- Performs QA review and approval of documentation related to small molecule and gene therapy contract manufacturing, packaging, labeling, and analytical records, as well as, other related documents as required by GMP regulation for Clinical and Commercial Supplies.
- This includes the review and approval of:
- Manufacturing/packaging records for precursors, Active Pharmaceutical Ingredients (API), drug substance, drug product (bulk and finished) and packaging, including but not limited to: master batch records, executed batch records, investigations, change orders, and releases;
- Plans, protocols, and reports associated with validation at company and CMOs, including process and analytical validation activities;
- Performing QA review of Chemistry | Manufacturing | Controls (CMC) documentation, including reviewing and approving manufacturing, packaging and analytical records.
- Reviewing SOPs related to GMPs.
- Completes all duties as per relevant procedures; always ensures compliance to cGMP.
- Performs other tasks and assignments as needed and specified by management.
- Bachelor's degree in a scientific discipline (preferably chemistry) or related experience in QA, or related role(s) in a pharmaceutical, biotechnology or related environment with a minimum of 6 years' experience and at least 2 years in a CMC-focused QA position.
- Detailed knowledge and understanding of GMP regulations and Food and Drug Administration (FDA) requirements.
- Demonstrated proficiency in application of QA principles, concepts, industry practices, and standards.
- Demonstrated knowledge and understanding of business practices and procedures associated with GxP Document Control, Change Control, CAPA, Deviation, and/or Lab investigations.
- Proficiency with Microsoft Office.
- Fluent in English (verbal and written).
- Excellent verbal and written communication skills.
- Ability to work virtually, independently and collaboratively.
- Analytical thinker with problem-solving skills.
skills: CMC, Quality Assurance, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.