A long-established research-based human health care company which discovers, develops, packages, and markets pharmaceutical products with a focus on neurology, oncology, Alzheimer's disease, epilepsy, and metabolic disorders is looking to bring on an experienced Sr. Quality Assurance Associate on a contract basis. The ideal Sr. QA Associate will prepare, review and issue required documentation including cGxP regulatory guidelines, provide oversight for the development and maintenance of quality programs, systems, and procedures that ensure compliance. This is a 12+ month contract role with possible extensions based onsite in Baltimore, MD; full benefits provided.
* Reviews executed commercial production records in a prompt manner, ensuring that records comply with GMP's and SOPs. Upon completion of review, assigns the appropriate disposition.
* Conducts, writes and performs risk assessments for investigations/deviations together with the production unit to fully understand the impact of deviations. Determines the root cause and assigns appropriate CAPAs.
* Contacts customers, conducts and writes investigation on product complaints, collaborates with the production unit to fully understand the impact of the complaint, and with support from production unit determines appropriate CAPAs.
* Drafts or contributes to QA documentation, including investigation reports, SOPs, and annual product reviews (APR)/product quality reviews (PQR).
* BS/BA or MS in Chemistry; or similar degree.
* 5-8 years of senior level experience providing Quality Assurance in the Pharmaceutical industry.
* Experience in batch records review, disposition, investigations, and deviations.
* Strong knowledge of cGMPs and Regulatory Guidelines; prior experience with regulatory inspections desired.