Position Overview
The Quality Specialist supports the Micro Sterility Assurance Laboratory by providing quality and compliance oversight for sterility assurance testing activities. This role ensures laboratory operations are conducted in accordance with GMP requirements, approved SOPs, and company quality standards. The incumbent will support routine and non-routine Micro Sterility Assurance testing activities, review documentation for accuracy and completeness, and partner with laboratory and quality teams to drive continuous improvement. In addition, this position will support process improvement initiatives through MPS, helping identify opportunities to improve efficiency, compliance, and operational performance.
The Quality Specialist is expected to maintain a strong understanding of GMP, SOPs, deviations, and other quality system requirements, while ensuring work is completed accurately, consistently, and in compliance with regulatory expectations.
Essential Functions
•Provide quality support to Micro Sterility Assurance laboratory operations and testing activities.
•Support Micro sterility assurance testing processes in accordance with GMP, SOPs, and applicable quality standards.
•Review laboratory documentation, records, and data for accuracy, completeness, and compliance.
•Assist in 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 process improvement initiatives using MPS to improve laboratory efficiency, standardization, and compliance.
•Participate in root cause analysis and problem-solving activities 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 the 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.
Qualifications
•Bachelor's degree in Microbiology, Biology, Biochemistry, Chemistry, or related scientific discipline preferred.
•1+ years of experience in a GMP-regulated environment, preferably in a microbiology or sterility assurance setting.
•Working knowledge of SOPs, deviations, investigations, and quality systems.
•Experience supporting laboratory testing and documentation review.
•Familiarity with continuous improvement tools and MPS principles preferred.
•Strong attention to detail, organizational skills, and analytical thinking.
•Effective communication and collaboration skills.
•Ability to work independently and within cross-functional teams.
Preferred Skills
•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.
The role is part of a 7-day operation and may require flexibility to support business and laboratory needs.
Required Skills: Adaptability, Analytical Instrumentation, Analytical Method Development, CAPA Management, Continuous Improvement Techniques, Deviation Management, Deviation Reporting, Driving Continuous Improvement, GMP Compliance, Good Lab Practices, Inspection Readiness, Laboratory Analysis, Laboratory Documentation, Laboratory Quality Control, Laboratory Safety, Microbiological Analysis, Quality Assurance (QA), Quality Improvement, Quality Metrics, Sterility Assurance, Teamwork, Technical Writing, Trend Monitoring, Troubleshooting, Use of Laboratory Equipment
Compensation
The salary range for the primary location of this role is $87,300.00 - $137,400.00. This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
Additional Details
•Employee Status: Regular
•Relocation: No relocation
•VISA Sponsorship: No
•Travel Requirements: No Travel Required
•Flexible Work Arrangements: Not Applicable
•Shift: 1st - Day
•Valid Driving License: No
•Hazardous Material(s): Yes
