GMP Documentation Specialist

Proclinical Staffing - Philadelphia, PA

Full-time

Philadelphia, PA

About the position

The GMP Documentation Specialist will play a crucial role in supporting documentation processes within a leading biotech company in Philadelphia, PA. This position involves drafting and approving Standard Operating Procedures (SOPs), Batch Records, Deviations, and Corrective and Preventive Actions (CAPAs), ensuring compliance with Good Manufacturing Practices (GMP) and regulatory standards. The specialist will lead investigations into nonconformances, manage change controls, and facilitate technology transfer, contributing to the overall efficiency and compliance of the documentation processes.

Responsibilities

• 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.

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).