GMP Documentation Specialist

GMP Documentation Specialist - Permanent - Philadelphia, PA

Proclinical is seeking a GMP Documentation Specialist to join an esteemed biotech company in Philadelphia, PA. In this role, you will support documentation processes, including drafting and approving SOPs, Batch Records, Deviations, and CAPAs.

Primary Responsibilities:

The successful candidate will lead teams in investigating nonconformances and deviations, manage change controls, and participate in technology transfer and technical information sharing. Your work will ensure compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).

Skills & Requirements:

• Bachelor's degree in biology, biochemistry, bioengineering, or related field, or equivalent industry experience.
• Strong technical knowledge of aseptic processing in cleanroom environments.
• Ability to build relationships and provide excellent support to staff.
• Proactive, results-oriented, and strong leadership skills.
• Ability to manage constant change and work in a fast-paced environment.
• Familiarity with 21 CFR Part 11, GxP best practices, and FDA regulations.
• Excellent written and verbal communication skills.
• Strong computer skills, problem-solving abilities, and attention to detail.
• Familiarity with data and sample management (LIMS/MES).
• Regular work week hours (1st shift M-F).

The GMP Documentation Specialist's responsibilities will be:

• Draft and approve SOPs, Batch Records, Deviations, and CAPAs.
• Perform revisions to accurately reflect current procedures.
• Lead investigations into nonconformances and deviations using root cause analysis.
• Draft and revise deviation reports to ensure timely resolution.
• Manage change controls for manufacturing areas and equipment.
• Coordinate document requests with supporting departments.
• Ensure timely review and approval of Batch Records and CAPAs.
• Seek and support new approaches to improve document review and revision efficiency.
• Adhere to GMP, SOPs, and Good Documentation Practices (GDP).
• Record data to comply with regulatory requirements.
• Attend weekly management meetings to discuss timelines and priorities.
• Contribute to projects to ensure timely completion.
• Troubleshoot and prioritize workload to resolve operational issues.
• Work independently and in a team environment.
• Ensure raw data records meet protocol specifications and GMP requirements.
• Review data generated by less experienced staff.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures.

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at 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.