Responsible for performing activities and reviews in support of the manufacture and disposition of product.
As a member of the Client Facing Quality Assurance team, you will be responsible for the critical, quality review of records associated with raw materials and product batch records ensuring compliance with established company procedures and policies as well as cGMP and all related regulatory agencies. He/she will need to embody the company vision and values.
Additional responsibilities of this role may include: Performing product inspections, line clearances, facility inspections, and general product observation, identifying quality events and assist with associated investigations.
You may also create, revise, review, and approve controlled documentation, log and monitor data and assist with uploading documentation into shared drive, support the client audits and regulatory inspections.
Minimum Qualifications:
Associates degree in a scientific discipline OR High School Diploma or GED AND 3+ years' experience in cGMP environment
2+ years' experience working in MS Word and Excel for editing documents
Preferred Qualifications:
Knowledge of governmental regulatory guidelines, directives, and regulations relating to the manufacture of biologics and pharmaceuticals
