GMP Compliance Coordinator

GMP Compliance Coordinator

Operations Leadership Jobs Vacaville, California

Description

Position at SBM Management 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.
• Conductinternal andexternal compliance audits, inspections, andfacilitywalkthroughs toidentifyrisks,ensureadherence toGMP, andverifytheintegrityofrecords and documentation.
• Coordinateandparticipateincustomer,internal,andregulatoryauditsbypreparingdocumentation,managingresponses,andaddressingfindingstomaintaincompliancereadiness.
• 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 recommendimprovementstoenhanceoverallperformanceandefficiency.

Quality Assurance & GMP Oversight

Training & Continuous Improvement

Cross-Functional Coordination

Recruitment & Operational Support

Qualification Education and / or Experience Bachelor’sdegreeinLifeSciences, QualityAssurance,orarelatedfieldpreferred.3–5yearsofexperienceincompliance,qualityassurance,orGMP-regulatedenvironments Knowledge, Skills, and Abilities StrongknowledgeofGMPregulations.Provenunderstandingofriskassessmentandmitigation.Experiencewithelectronic QualityManagement Systems(eQMS) anddocumentcontrol.Excellent analytical, research, communication, and organizational skills.

Compensation : $75, - $80, Yearly

Benefits Include : Medical / Dental / Vision and k

Shift : First  Shift

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