Quality Control, Analyst II
Skills
- Strong aseptic technique and cleanroom behavior
- Experience with environmental monitoring methods (viable and non-viable)
- Proficiency with statistical analysis tools (e.g., JMP) and LIMS
- Knowledge of FDA, EMA, and ICH regulations related to EM and GMP
- Experience performing investigations, root cause analysis, and CAPA implementation
- Good written and verbal communication skills and documentation practices
- Ability to mentor junior staff and lead EM initiatives
- Willingness to work flexible hours to support production schedules
Responsibilities
- Lead and coordinate environmental monitoring (EM) sampling activities in classified cleanrooms, including viable and non-viable air, surface, and personnel monitoring.
- Perform data analysis and trending using statistical tools and LIMS; prepare reports for internal stakeholders and regulators.
- Lead investigations for OOS/deviations, perform root cause analysis, and implement CAPAs.
- Mentor and train junior QC analysts on EM techniques, aseptic behavior, and GMP documentation.
- Support and lead EM-related activities during media fills, process simulations, and EMPQ.
- Author and review SOPs, protocols, and technical reports related to EM.
- Collaborate with Manufacturing, QA, and Facilities to maintain environmental control and compliance.
- Participate in audits and inspections as a subject matter expert for EM practices.
- Drive continuous improvement and implement new technologies/process optimizations within the EM program.
Education
- Bachelor’s degree in Microbiology, Biology, or related scientific field required
- Relevant GMP/QC training and certifications preferred
Benefits
- Health, dental, and vision insurance
- 401(k) retirement plan with company match
- Paid time off and paid holidays
- Professional development and training opportunities
- Employee assistance programs and wellness resources
Average salary estimate
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