Manufacturing GDP Specialist
About The Position
The Manufacturing GDP Specialist ensures the integrity and compliance of manufacturing documentation by tracking, reviewing, and correcting batch records and logbooks in accordance with Good Documentation Practices (GDP) and applicable regulatory requirements. The role partners with Manufacturing Technicians to drive timely error correction, maintains error-tracking metrics to identify and address repeated GDP violations, and coaches shopfloor personnel on GDP principles. It helps safeguard the safety, efficacy, and quality of drug substance by identifying and escalating GDP-related issues, supporting batch record simplification, and contributing to deviation investigations and CAPA development. The role is accountable for documentation accuracy, batch record review cycle time, and fostering a culture of quality and compliance across manufacturing operations. The position is based in Pearl River, New York, and involves working in a manufacturing environment, including cleanroom gowning requirements. It requires regular walking and standing during shopfloor reviews and interactions with Manufacturing Technicians, occasional lifting up to 25 pounds, and flexibility to respond to documentation or compliance issues outside standard business hours as needed.
Requirements
- High school diploma or equivalent.
- At least 1 year of experience in a GMP-regulated manufacturing environment.
- Working knowledge of Good Documentation Practices (GDP) and cGMP regulations, including 21 CFR Parts 210 and 211.
- Familiarity with batch record review and manufacturing logbook requirements.
- Highly detail-oriented, with the ability to work quickly and accurately.
- Sound interpersonal and information-gathering skills.
- Ability to work effectively in a team and interact with people across all levels.
- Strong written and verbal communication skills.
- Proactive, quality-focused mindset.
- Demonstrated attention to detail and accuracy in documentation-focused tasks.
- Ability to work quickly and accurately under time constraints.
- Ability to work in a manufacturing environment, including cleanroom gowning requirements.
- Regular walking and standing during shopfloor reviews and interactions with Manufacturing Technicians; occasional lifting up to 25 pounds.
- Flexibility to respond to documentation or compliance issues outside standard business hours, as needed.
Nice To Haves
- Associate or bachelor's degree in a science, engineering, or related field.
- Prior experience in biopharmaceutical, pharmaceutical, vaccine, biologics, or equivalent industries.
- Exposure to electronic batch record (EBR) systems.
- Lean Manufacturing or continuous improvement training.
- Understanding of deviation investigation and CAPA processes.
- Basic knowledge of error-tracking and metrics-reporting tools, such as Excel or electronic batch record systems.
Responsibilities
- Track and review manufacturing batch records and logbooks for compliance with GDP and regulatory requirements.
- Follow up with Manufacturing Technicians to ensure corrections are completed in a timely manner.
- Ensure batch record review cycle-time targets are consistently met.
- Maintain error-tracking metrics to identify, address, and correct repeated GDP violations.
- Review batch record structure and recommend simplifications to minimize errors, as applicable.
- Coach shopfloor technicians on GDP principles and best practices.
- Identify and escalate GDP issues that could affect the safety, efficacy, and quality of drug substance.
- Participate in deviation investigations and CAPA creation, as applicable.
- Support regulatory inspections and internal audits related to documentation practices.
- Collaborate with Manufacturing, Quality, and shopfloor teams.
- Serve as a key point of contact for GDP-related questions and shopfloor guidance.
Benefits
- Health and wellbeing benefits, including high-quality healthcare and prevention and wellness programs.
- At least 14 weeks of gender-neutral parental leave.
- Company employee benefit programs; additional benefits information is available from the company.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
