GMP Compliance Coordinator

Overview

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.
• Audits and Inspections : 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.
• Audit Readiness : Coordinate and participate in customer, internal, and regulatory audits by preparing documentation, managing responses, and addressing findings to maintain compliance readiness.
• Data & KPIs : 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

Training & Continuous Improvement

Cross-Functional Coordination

Recruitment & Operational Support

Qualifications

Education and / or Experience

Knowledge, Skills, and Abilities

Compensation : $75,000 - $80,000 Yearly

Benefits Include : Medical / Dental / Vision and 401k

Shift : First

Equal Opportunity Employer 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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