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