Quality Assurance Representative

Proclinical is currently recruiting for a Quality Assurance Representative with a pharmaceutical company located in Philadelphia, PA.

Job Responsibilities:

• Focused QA Representative on review/approval of Non-Conforming Events (NCEs), Deviations, Laboratory Investigations (OOS), and CAPA's; will coach/mentor Laboratory personnel in development of technical writing skills.
• Ensures site adherence to Quality Systems.
• Perform timely review of complex study files, such as: Assay Validations, Process Validations, and Viral Clearance.
• Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (ie: ICH, ISPE, etc.).
• Maintains awareness of activities by routine direct observation of testing laboratories and manufacturing suites. Interact frequently with operations/facility staff to provide quality perspective on routine operations and support systems. Address conditions/practices with appropriate personnel, documents and reports findings to Management.
• Compiles and reviews raw data / laboratory test results, including Final Reports and CoA's, in accordance with cGMP, cGLP, Code of Federal Regulations (CFR), Points to Consider (PTC) guidelines and internal procedures in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained.
• Write and revise SOPs as necessary.

Skills and Requirements:

• 7 or more years of experience
• Bachelors' degree in a Science related field or equivalent experience

If you are having difficulty in applying or if you have any questions, please contact Dominic Santoro at 215-531-6914.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-DS1