QA Specialist - Malvern, PA
Responsibilities:
- Maintain and improve the site's Quality Management System.
- Oversee the site's compliance with cGMPs, corporate policies, and procedures.
- Creation and maintenance of controlled documentation, including SOPs, Analytical Data, COAs, Methods of Analysis, etc.
- Review and approval of change control, deviations, CAPAs, and LIRs.
- Administrator of site training including scheduling, re-training, and training on revised documentation.
- Review and approve documentation for the disposition of GMP components, raw materials, intermediates, and APIs.
- Review and approve master and executed batch records for GMP campaigns.
- Assist in audits.
Qualifications:
- Bachelor's of Science Degree with 3-5 years of industry experience
- Knowledge of regulatory compliance including 21CFR Part 211
- Strong organizational skills and detail oriented
- Strong technical writing skills
- Ability to work independently to meet tight deadlines.
- Experience working in a synthetic and/or analytical laboratory environment with a focus on small molecule pharmaceuticals highly preferred
- QA experience in contract manufacturing for the small molecule arena of the pharmaceutical industry preferred.
- Experience with OSHA regulations preferred