GMP Compliance Coordinator
Description
GMP Compliance Coordinator is a pivotal role in ensuring adherence to Good Manufacturing Practice (GMP) standards at our customer’s FDA regulated facility. This position oversees the management of GMP documentation, employee training, and quality assurance processes to uphold regulatory compliance, service quality, and operational excellence. The GMP Compliance Coordinator will collaborate with cross-functional teams to maintain accurate records, update standard operating procedures (SOPs), and support audits while fostering a culture of compliance through training and mentorship; proactively monitoring processes, facilitating deviation investigations, and driving continuous improvement. The GMP Compliance Coordinator works closely with various departments to ensure that all manufacturing, testing, and documentation processes meet the high-quality standards necessary for product safety, efficacy, and legal compliance. This role offers administrative and operational support to both office and lab services activities. Position is onsite.
Roles & Responsibilities
Compliance Management & Auditing
- Develop, evaluate, and revise compliance programs, internal controls, and standard operating procedures (SOPs) to meet evolving regulatory and customer requirements.
- Conduct internal and external compliance audits, inspections, and facility walkthroughs to identify risks, ensure adherence to GMP, and verify the integrity of records and documentation.
- Coordinate and participate in customer, internal, and regulatory audits by preparing documentation, managing responses, and addressing findings to maintain compliance readiness.
- Compile and analyze internal and external audit data to support reporting, metrics, and trend analysis. Monitor compliance KPIs (e.g., deviations, CAPAs, training completion, and audit outcomes) and recommend improvements to enhance overall performance and efficiency.
Quality Assurance & GMP Oversight
- Ensure company and customer quality management systems conform to all regulatory, legal, and customer standards.
- Devise and review specifications for products, processes, and validation records to maintain quality control and system qualification.
- Manage GMP logbooks, document control, and data integrity (ALCOA+) across all systems to ensure traceability and compliance with documentation standards.
- Maintain and support eQMS systems, including workflows for training, document control, deviations, and CAPAs.
- Coordinate facility and lab compliance programs, including GMP cleaning verification, lab glassware sterilization, and inspection readiness.
Training & Continuous Improvement
- Design, deliver, and evaluate compliance and GMP training for new hires and existing staff, ensuring understanding of SOPs, safety protocols, and regulatory requirements.
- Mentor and shadow production employees to reinforce GMP standards, provide real-time feedback, and support continuous improvement in operational practices
- Stay current on evolving regulations and best practices through continuing education and professional development.
- Promote a culture of compliance and quality by driving process optimization, risk mitigation, and employee engagement initiatives.
Cross-Functional Coordination
- Collaborate with Quality Assurance, Production, Engineering, and external partners to resolve compliance and procedural issues.
- Communicate with internal and external quality teams regarding deviations, incidents, and corrective actions.
- Facilitate deviation meetings, root cause analyses, and CAPA development to prevent recurrence of non- conformances.
- Provide administrative and operational support, including scheduling, documentation management, and
- logistics coordination to support cross-functional efficiency.
Recruitment & Operational Support
- Participate in interviewing, selecting, and onboarding staff to ensure alignment with company quality and compliance expectations.
- Partner with staffing agencies to ensure hiring processes meet regulatory and company standards. Serve as a key contact during emergency or after-hours incidents, coordinating responses and maintaining safety and GMP compliance.
- Other duties as assigned.
Qualification
Education and/or Experience
Bachelor’s degree in Life Sciences, Quality Assurance, or a related field preferred.
3–5 years of experience in compliance, quality assurance, or GMP-regulated environments
Knowledge, Skills, and Abilities
Strong knowledge of GMP regulations.
Proven understanding of risk assessment and mitigation.
Experience with electronic Quality Management Systems (eQMS) and document control.
Excellent analytical, research, communication, and organizational skills.
Compensation: $75,000 - $80,000 Yearly
Benefits Include: Medical/Dental/Vision and 401k
Shift: First Shift
SBM Management Services, LP and its affiliates are proud to be equal opportunity workplaces. We are committed to equal employment opportunity regardless of race, sex, color, ancestry, religion, national origin, sexual orientation, citizenship, age, marital status, disability, gender identity, Veteran status, or other legally protected status.
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