Job Description

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

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