Apply on Employer Site

SBM Management Services, LP · 1 day ago

GMP Compliance Coordinator

Portsmouth, NH

Full-time

Onsite

Mid Level

3+ years exp

SBM Management Services, LP is seeking a GMP Compliance Coordinator to ensure adherence to Good Manufacturing Practice (GMP) standards at an FDA regulated facility. The role involves managing GMP documentation, employee training, and quality assurance processes while collaborating with cross-functional teams to maintain compliance and operational excellence.

ConsultingInformation TechnologyLegal

Responsibilities

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

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

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

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-conformance

Provide administrative and operational support, including scheduling, documentation management, and logistics coordination to support cross-functional efficiency

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