Airswift is looking for a QC Remediation Specialist to support one of our clients in Lannon, WI.
The QC Remediation Specialist provides hands-on laboratory and data support response and remediation activities. The role manages retain samples, supports laboratory and microbiological investigations, compiles and reviews analytical data such as TOC results, and supports execution of process and cleaning validation. The role works closely with the QA Remediation Specialist and designated microbiology resources.
Key responsibilities
- Pull, track, and manage retain and reserve samples required for 483 response and remediation activities, maintaining chain of custody and inventory records.
- Coordinate retain sample testing, including sample preparation, submission to internal or contract laboratories, and results tracking.
- Conduct and support laboratory investigations, including OOS, OOT, and laboratory deviations, with phase I/II investigation documentation and root cause analysis.
- Assist in microbiological investigations (e.g., environmental monitoring excursions, bioburden, water system, and microbial limits failures) in collaboration with client's personnel and designated microbiology resources.
- Provide data and technical input to QA-led risk assessments, product impact assessments, and CAPAs; implement laboratory-related CAPA actions.
- Compile, review, and trend Total Organic Carbon (TOC) results and integrate them into cleaning validation documentation and assessments.
- Support cleaning validation execution, including swab and rinse sampling, sample handling, and verification of analytical method suitability and recovery data.
- Support process validation execution, including sampling plans, sample testing coordination, and analytical data review and compilation for protocols and reports.
- Perform second-person review of laboratory data, notebooks, chromatography, and instrument records for accuracy, completeness, and data integrity.
- Draft and revise QC laboratory SOPs, test methods, and work instructions; deliver training to laboratory personnel on revised procedures.
- Support inspection readiness of the QC laboratory, including document retrieval and laboratory walkthrough preparation.
- Provide general quality, compliance, and validation
Required qualifications
- Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry, or a related scientific field.
- 5+ years of Quality Control laboratory experience in an FDA-regulated pharmaceutical, OTC, API, or chemical manufacturing environment.
- Experience managing retain samples, stability samples, or sample inventory under cGMP.
- Demonstrated experience conducting OOS/OOT and laboratory investigations per FDA guidance on investigating OOS results.
- Hands-on experience with TOC analysis and data (e.g., Shimadzu analyzers) and their use in cleaning validation.
- Working knowledge of microbiological testing and investigations, including environmental monitoring, bioburden, water testing, and USP <61>/<62>.
- Familiarity with common analytical techniques such as HPLC, GC, UV-Vis, FTIR, and wet chemistry.
- Working knowledge of 21 CFR Parts 210/211, 21 CFR Part 11, USP general chapters, and ALCOA+ data integrity principles.
- Experience supporting process validation and cleaning validation execution and data packages.
- Strong technical writing skills and meticulous attention to detail in data review.
Preferred qualifications
- Experience supporting FDA Form 483 or Warning Letter remediation in a QC laboratory.
- Chemistry degree. Microbiology laboratory experience a plus.
- Experience with LIMS and chromatography data systems (e.g., OpenLab, Empower).
- Knowledge of analytical method validation and verification (ICH Q2(R2), USP <1225>/<1226>).
Core competencies
- Analytical problem solving and scientific judgment
- Precision and thoroughness in documentation and data review
- Collaboration with QA, manufacturing, and contract laboratories
- Ability to prioritize multiple remediation tasks under tight timelines
- Clear verbal and written communication
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