Category: Scientific & Clinical
Quality Associate Batch Record Review
- BS in a scientific discipline or equivalent with a minimum 3-5 years’
- MS in a scientific discipline or equivalent with a minimum of 1-3 years’ experience
- Experience working in an FDA regulated industry
- Rreally would prefer someone with experience with batch records, CAPA’s, QC data review in a GMP environment).
- Experience with Quality Assurance oversight and support for all phases of clinical trials.
- Experience with Microsoft Office and other complex computer software
- Experience with commercial phase pharmaceuticals
- EMEA experience
- Perform review and release of Regulatory Starting Materials, Intermediates and Active Pharmaceutical Ingredients (APIs)
- Support of clinical and commercial product manufacturing.
- Assist in the development, implementation, and maintenance of quality systems, related
- Review and approve master and executed batch records, deviations, OOS/OOT investigations, test method qualifications and validations, stability and Quality Control data and reports compliance to internal and GMP standards.
- Identify issues that may impact products or failures to comply with local or regulatory
- Represent the department during project meetings, client audits and FDA inspections, if needed.
- Write and revise Standard Operating Procedures (SOPs) as required.
- Review master documents such as In-process forms and Batch Records.