GCP Director ensuring compliance in clinical trials for Evolution Research Group. Overseeing quality assurance and operations at the Clinical Pharmacology of Miami site.
About the role
- Lead product release execution and data management related to food safety at Chobani's Twin Falls site. Manage microbiological testing programs ensuring compliance and timely product disposition.
Responsibilities
- Own finished product and in-process release readiness, serving as the primary decision maker for release, hold, rework, remix, or destruction during assigned shifts, weekends, and off-production days
- Lead and manage the site microbiology laboratory program, including test execution, method validation, troubleshooting, and continuous improvement
- Coordinate and oversee all stages of analytical and microbiological testing, ensuring testing timelines align with production and release schedules
- Ensure compliance with FSQA, GMP, GLP, food safety, and regulatory requirements, maintaining audit-ready documentation and data integrity
- Independently assess testing results, deviations, and food safety risk; escalate high-risk or non-standard issues to senior quality leadership as required
- Author, maintain, and update microbiology SOPs, test methods, and work instructions to ensure accuracy, compliance, and consistency
- Lead investigations, corrective actions, and root cause analysis for non-conforming or invalid results; support nonconformance tracking and trending
- Provide off-hours and on-call FSQA leadership support to Operations, Sanitation, and Supply Chain to coordinate holds, rework, and release activities to minimize downtime and ensure timely product shipments
- Oversee sample receipt, handling, storage, and external testing coordination; ensure timely and accurate communication of results to key stakeholders
- Provide functional oversight and technical direction to laboratory technicians and cross-functional partners related to microbiological testing, release processes, and product disposition
- Own LIMS and SAP data accuracy, reporting, and data integrity for microbiology and release testing; ensure timely reporting and audit readiness
- Support testing activities for key projects and studies, including shelf-life, method development, and process validation, under leadership guidance
- Follow and enforce Chobani safety procedures and Good Manufacturing Practices (GMPs)
Requirements
- Bachelor’s degree in food science, microbiology, or related field, or equivalent relevant experience in food and/or pharmaceutical manufacturing environments
- In-depth knowledge of food microbiology principles and microbiological test procedures
- Minimum of 2 years of experience in a laboratory setting (industry and/or academic)
- Demonstrated attention to detail and strong commitment to quality and data integrity
- Strong verbal and written communication skills with the ability to convey technical information clearly
- Excellent troubleshooting, analytical, and critical-thinking skills with the ability to work under pressure and make independent decisions
- Familiarity with standard analytical and microbiological methods used in food manufacturing
- Skilled and knowledgeable in Good Laboratory Practices (GLPs) and regulatory expectations
- Experience working with Laboratory Information Management Systems (LIMS) and SAP systems
- Highly organized with the ability to manage multiple priorities, projects, and deadlines in a fast-paced environment
- Ability to work independently with minimal supervision while also collaborating effectively within a team in a fast paced dynamic environment
- Ability to understand, record, analyze, and communicate technical data and trends
- Ability to meet physical demands associated with laboratory and manufacturing environments, including wet and cold conditions
- Ability to work non-standard schedules as required by business need, including weekends, off-production days, and on-call responsibilities
- Strong organizational, project management, and time-management skills
- Ability to collaborate effectively with both technical and non-technical teams.
Benefits
- medical, dental, vision coverage
- disability insurance
- health savings account
- flexible spending accounts
- tuition reimbursement
- 401k match of 100% on up to 5% of eligible pay
- fertility and childcare assistance
- 12 weeks of parental leave at full pay after six months of continuous employment
- wellness resources including employee assistance program, fitness discounts, wellness reimbursement, on-site gym access (certain locations) and monthly wellness newsletter
- 120 hours of paid time off
- 11 holidays
- paid volunteer time off
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