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 helps ensure laboratory operations comply with GMP requirements, approved SOPs, company quality standards, and regulatory expectations. The specialist supports routine and non-routine testing, reviews documentation for accuracy and completeness, and works with laboratory and quality teams on continuous improvement and process improvement initiatives through MPS. The role requires maintaining a working understanding of GMP, SOPs, deviations, and other quality-system requirements, while completing work accurately and consistently. The position is part of a 7-day operation and may require flexibility to support business and laboratory needs. The position is based primarily in West Point, Pennsylvania, and is a first-shift role.
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.
- Ability to support a 7-day operation and flexibility to meet business and laboratory needs.
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, and vision healthcare benefits.
- Other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays.
- Vacation.
- Compassionate and sick days.
- Eligible for an annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
