57 East Willow Street Millburn, NJ 07041 US
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.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.