QA Associate
57 East Willow Street Millburn, NJ 07041 US
Job Description
Responsibilities include but are not limited to:
- Responsible for support of manufacturing operations such as batch record issuance and reconciliation activities.
- Review of GMP documentation, which includes conducting independent documentation review of executed cGMP records.
- Work closely with the production, quality control and supply chain departments to ensure their practice fully adheres to GDP practices and procedures.
- Establishment of systems and work streams compliant with approved site procedures and GDP associated with the sites batch record documentation.
- Key Performance Indicator (KPI) tracking and reporting for the established work streams.
- Work closely with Document Control to ensure appropriate handover of GMP executed records.
The ideal candidate will bring the following to the role:
- Bachelors Degree Preferred; Biology and/or microbiology background also preferred.
- Experience with cGMP systems and practices, preferable involving document control, quality assurance, or quality systems.
- Maintain Weekly and Daily targets to support the QA Operations team goals. This includes working in an organized fashion.
- Ability to gown aseptically and work in controlled non-classified areas.
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