Kelly Science & Clinical is seeking a Senior Quality Control Supervisor near Eau Claire, WI.
Shift: Monday - Friday 8am-5pm
Compensation: $85,000- $94,000 DOE
Position Overview
We are seeking a highly skilled and experienced Quality Control Supervisor to ensure the proficiency and optimal functioning of our factory laboratory, providing top-tier analytical services. The ideal candidate will be responsible for maintaining Good Laboratory Practices (GLPs) in compliance with regulatory requirements, including standard operating procedures, instrument validation and calibration, change control, and technical expertise development in laboratory systems.
Key Responsibilities
Leadership and Development
- Lead and develop laboratory professionals, providing coaching, guidance, and evaluations to maintain a competent team.
- Hire, direct, and manage laboratory employees in both the Quality Control and satellite laboratories.
- Communicate regularly with Factory Operations, internal support functions, and external contractors to ensure smooth lab operations.
Laboratory Operations
- Oversee the effective and compliant operation of the main and satellite laboratories, ensuring equipment availability and quality control.
- Validate and establish new and existing methods in accordance with FDA requirements, and manage qualification/validation/verification protocols.
- Coordinate and oversee analyses performed by subcontracted laboratories.
- Support factory operations by implementing updated or alternative methods and establishing monitoring plans.
- Ensure high-quality analysis through validated methods and regular performance testing.
- Address laboratory audit gaps and deviations with effective investigation and resolution.
Quality System Management
- Maintain and regularly update the laboratory quality system in compliance with regulatory and ISO standards.
- Manage shelf life, stability, and finished product compliance monitoring programs.
- Provide expert support for validation activities, including physio-chemical and microbiological analyses.
Audit Readiness and Compliance
- Ensure readiness for internal and external audits, following up on proficiency test results and inter-laboratory comparisons.
- Lead root cause analysis for unacceptable results and implement corrective actions.
- Oversee regular maintenance and calibration of laboratory instruments and equipment.
Project Support
- Support industrialization and product launch projects from an analytical perspective.
Safety Leadership
- Ensure a safe working environment by enforcing Good Laboratory Practices, Laboratory Safety Standards, and Biosafety/Biosecurity Protocols.
- Provide safety coaching to laboratory personnel and visitors.
Qualifications
Education
Required: Bachelor's Degree in Microbiology, Chemistry, Food Science, or related field.
Preferred: Master’s of Science or MBA.
Experience
Required:
- 3+ years in a quality supervision role within a manufacturing environment.
- Minimum of 3 years of Quality Control experience.
Preferred:
- Experience in the Infant Formula or Pharmaceutical industry.
Skills
- Strong leadership and team development abilities.
- Strategic organizational skills and ability to work under pressure.
- Service-oriented with a strong attention to detail.
- Proficiency in Microsoft Word, Excel, and SAP (preferred).
- Expertise in microbiological, chemical, and nutritional analyses, including in-line testing and inspection.
- Excellent problem-solving skills and ability to make quick, accurate decisions.
- Experience with SPC, statistical inference, and budgeting.