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GMP Document Control Specialist - Contract - Durham, NC

Are you looking to make an impact with your innovation? We are working with a well-established pharmaceutical company to recruit for a dedicated document controller.

ÌìÑÄÉçÇø¹ÙÍø is seeking a skilled and dynamic GMP Document Control Specialist to support production operations by ensuring compliance with GMP and GDP standards.

Primary Responsibilities:

This role focuses on batch documentation review, troubleshooting, and continuous improvement of quality processes. You will play a key part in maintaining high-quality standards and supporting the production team in meeting regulatory requirements.

Skills & Requirements:

• Background in technology, science, pharmaceuticals, or equivalent industrial/military/vocational training.
• Experience in GMP-regulated environments and pharmaceutical documentation, including batch reports and SOPs.
• Familiarity with regulatory authority requirements (e.g., FDA).
• Proficiency in IT systems such as Adobe, Excel, SAP, and material control systems.
• Strong problem-solving skills and attention to detail.
• Excellent written and oral communication skills.
• Ability to establish and maintain cross-organizational networks and facilitate knowledge sharing.
• Willingness to learn new IT systems and adapt to evolving priorities.

The Document Control Specialist's responsibilities will be:

• Provide routine support and troubleshooting for batch documentation review processes in production operations.
• Ensure batch documentation, SOPs, and other standardized documents meet internal and external compliance requirements.
• Address challenges and clarifications to ensure high-quality batch reviews.
• Continuously improve batch review systems to align with production plans.
• Issue and track all batch-related documentation.
• Drive the establishment and improvement of batch review and documentation processes.
• Support Annual Product Review (APR) documentation.
• Review and approve executed batch production records (BPRs) for accuracy and compliance.
• Conduct real-time reviews of BPRs, logbooks, and related documentation.
• Ensure site compliance with cGMPs, ISO standards, and corporate/local SOPs.
• Act as an SOP owner and reviewer.
• Coach production employees on quality-related activities.
• Generate and implement ideas for process improvements.
• Support minor deviations and adjust to changing priorities as needed.

Compensation:

• $18 to $22 per hour.

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

ÌìÑÄÉçÇø¹ÙÍø is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ÌìÑÄÉçÇø¹ÙÍø is acting as an Employment Agency in relation to this vacancy.

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