Specialist, Operational Quality Control
About The Position
The Quality Specialist supports the Micro Sterility Assurance Laboratory by providing quality and compliance oversight for sterility assurance testing activities. The role ensures laboratory operations are conducted in accordance with GMP requirements, approved SOPs, company quality standards, and regulatory expectations. The incumbent supports routine and non-routine testing, reviews documentation for accuracy and completeness, and partners with laboratory and quality teams to drive continuous improvement. The position also supports process improvement initiatives through MPS to identify opportunities to improve efficiency, compliance, and operational performance. The Quality Specialist maintains a strong understanding of GMP, SOPs, deviations, and other quality system requirements, ensuring work is completed accurately and consistently. Responsibilities include supporting laboratory testing and quality systems, assisting with investigations and corrective actions, contributing to audits and inspection readiness, monitoring trends, and participating in daily tier meetings. The role is part of a 7-day operation and may require flexibility to support business and laboratory needs.
Requirements
- At least 1 year of experience in a GMP-regulated environment, preferably in microbiology or sterility assurance.
- Working knowledge of SOPs, deviations, investigations, and quality systems.
- Experience supporting laboratory testing and documentation review.
- Strong attention to detail, organizational skills, and analytical thinking.
- Effective communication and collaboration skills.
- Ability to work independently and within cross-functional teams.
- Adaptability; analytical instrumentation; analytical method development; CAPA management; continuous improvement techniques; deviation management and reporting; GMP compliance; good laboratory practices; inspection readiness; laboratory analysis, documentation, quality control, and safety; microbiological analysis; quality assurance; quality improvement and metrics; sterility assurance; teamwork; technical writing; trend monitoring; troubleshooting; and use of laboratory equipment.
- The role may require flexibility to support business and laboratory needs in a 7-day operation.
Nice To Haves
- Bachelor’s degree in Microbiology, Biology, Biochemistry, Chemistry, or a related scientific discipline.
- Familiarity with continuous improvement tools and MPS principles.
- Experience in sterility assurance, microbiological testing, or quality assurance laboratory support.
- Understanding of CAPA, change control, and audit readiness processes.
- Ability to support process improvement and standardization efforts.
- Strong problem-solving mindset and commitment to compliance.
Responsibilities
- Provide quality support to Micro Sterility Assurance laboratory operations and testing activities.
- Support microbiological sterility assurance testing in accordance with GMP, SOPs, and applicable quality standards.
- Review laboratory documentation, records, and data for accuracy, completeness, and compliance.
- Assist with deviation investigation, documentation, and follow-up actions.
- Support quality system activities, including change control, documentation review, and CAPA where applicable.
- Partner with laboratory staff and quality representatives to ensure compliance and timely resolution of quality issues.
- Contribute to MPS process improvement initiatives to improve laboratory efficiency, standardization, and compliance.
- Participate in root cause analysis and problem-solving related to laboratory quality events.
- Ensure adherence to data integrity, documentation practices, and good laboratory practices.
- Support internal audits, inspection readiness, and other quality-related assessments as needed.
- Monitor trends, identify recurring issues, and recommend corrective and preventive actions.
- Assist with implementation and maintenance of quality metrics and continuous improvement plans.
- Participate in daily tier meetings to review priorities, escalate issues, track action items, and support timely resolution of operational and quality concerns.
Benefits
- Medical, dental, vision, healthcare, and other insurance benefits for employees and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Annual bonus eligibility
- Long-term incentive eligibility, if applicable
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
