Pharmaceutical Quality Assurance Specialist

Proclinical seeking a Pharmaceutical Quality Assurance Specialist for a leading biotech company located in Philadelphia, PA.

Must be eligible to work in the US.

Job Responsibilities:

• Perform Quality reviews, organize and file records that support operation activities for clean room suite manufacturing of a commercial ready raw material.
• Support quality assurance processes, controls and batch history files for QA Operations and Lot Disposition
• Support the efficient and timely reviews of batch records, testing, equipment, room qualification, training and other related records.
• Support clean room readiness, environmental monitoring, gowning qualifications, line clearances, and room release.
• Prepare release documentation for approvals.
• Support GDP investigations as needed.
• Support QA and Logistics activities for on-going projects
• Assist with implementing GMP QA procedures
• Other duties as assigned

Skills and Requirements:

• BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college with 3-6 years of relevant experience
• Detailed knowledge of Code of Federal Regulations and International Council for Harmonization Guidelines governing current Good Manufacturing Practices for Pharmaceuticals
• Excellent oral and written communication skills
• Ability to identify and resolve quality issues with others in a proactive, diplomatic, flexible, and constructive manner.
• Must be comfortable in a fast-paced environment and changing priorities.
• Experience with use of an electronic QMS, MasterControl, Veeva preferred
• Proficient with Microsoft Office Suite, Word, Excel, and PowerPoint

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at +(1) 215-531-6914 or s.briggs@proclinical.com.

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-SB7

INDCQA