QC Specialist III/IV
Alkermes
3 days ago
On-site
Cincinnati Metropolitan Area
Operations
Quality Control QC Specialist III/IV: Responsible for lifecycle management, compliance, and performance of analytical instrumentation in Quality Control laboratories, ensuring instrument qualification, calibration, maintenance, troubleshooting, and data integrity meet regulatory expectations (FDA, ICH, JP).
Major Responsibilities
- Oversee lifecycle management of chemistry/microbiology instruments (HPLC, UPLC, GC, LC-MS, UV-Vis, FTIR, dissolution systems, TOCs, Particle Counters, MAS-100 Viable Air Sampler, and other analytical platforms).
- Lead installation, qualification, and validation (IQ/OQ/PQ) in compliance with regulatory guidelines.
- Maintain validated state through calibration, preventive maintenance, and requalification.
- Manage instrument asset tracking systems and documentation.
- Support risk assessments to ensure compliance of instrumentation, software, and data systems (ICH Q9) and data governance policy.
- Develop/review/approve SOPs, protocols, and reports for instrumentation.
- Support audits and regulatory inspections.
- Support investigations, deviations, OOS, and OOT results related to instrumentation.
- Serve as SME for troubleshooting/root cause analysis; coordinate with vendors.
- Evaluate/implement new technologies, software, and analytical tools; support method transfers.
- Lead/support cross-functional projects (lab expansions, new equipment, digital transformation); drive continuous improvement; manage change control.
- Maintain records for calibration/maintenance/qualification/deviations; oversee CSV; support data system configuration/compliance (e.g., Empower, LIMS).
- Train/mentor QC specialists (and QC analysts as requested).
Skills/Competencies
- Deep knowledge of instrument qualification/validation (IQ/OQ/PQ).
- Data integrity and compliance knowledge; strong troubleshooting/root cause analysis.
- Experience with Empower/LIMS/CDS systems; Maximo; strong technical writing/documentation; project leadership and communication/collaboration.
Education/Experience
- QC Specialist III: BS Chemistry (3–4 years) or MS Chemistry (2 years).
- QC Specialist IV: BS Chemistry (5 years) or MS Chemistry (3 years).
Major Responsibilities
- Oversee lifecycle management of chemistry/microbiology instruments (HPLC, UPLC, GC, LC-MS, UV-Vis, FTIR, dissolution systems, TOCs, Particle Counters, MAS-100 Viable Air Sampler, and other analytical platforms).
- Lead installation, qualification, and validation (IQ/OQ/PQ) in compliance with regulatory guidelines.
- Maintain validated state through calibration, preventive maintenance, and requalification.
- Manage instrument asset tracking systems and documentation.
- Support risk assessments to ensure compliance of instrumentation, software, and data systems (ICH Q9) and data governance policy.
- Develop/review/approve SOPs, protocols, and reports for instrumentation.
- Support audits and regulatory inspections.
- Support investigations, deviations, OOS, and OOT results related to instrumentation.
- Serve as SME for troubleshooting/root cause analysis; coordinate with vendors.
- Evaluate/implement new technologies, software, and analytical tools; support method transfers.
- Lead/support cross-functional projects (lab expansions, new equipment, digital transformation); drive continuous improvement; manage change control.
- Maintain records for calibration/maintenance/qualification/deviations; oversee CSV; support data system configuration/compliance (e.g., Empower, LIMS).
- Train/mentor QC specialists (and QC analysts as requested).
Skills/Competencies
- Deep knowledge of instrument qualification/validation (IQ/OQ/PQ).
- Data integrity and compliance knowledge; strong troubleshooting/root cause analysis.
- Experience with Empower/LIMS/CDS systems; Maximo; strong technical writing/documentation; project leadership and communication/collaboration.
Education/Experience
- QC Specialist III: BS Chemistry (3–4 years) or MS Chemistry (2 years).
- QC Specialist IV: BS Chemistry (5 years) or MS Chemistry (3 years).