QC Specialist III/IV
Alkermes
June 26, 2026
On-site
Cincinnati Metropolitan Area
Operations
Quality Control QC Specialist III/IV
Responsibilities
- Oversee lifecycle management of QC laboratory analytical instrumentation (e.g., HPLC, UPLC, GC, LC-MS, UV-Vis, FTIR, dissolution/TOCs, Particle Counters, MAS-100 Viable Air Sampler).
- Lead installation, qualification, and validation activities (IQ/OQ/PQ) per regulatory guidelines.
- Maintain validated instrument state through calibration, preventive maintenance, and requalification.
- Manage instrument asset tracking and documentation.
- Support risk assessments to ensure instrumentation, software, and data systems comply with data governance and ICH Q9 data integrity principles.
- Develop/review/approve instrumentation SOPs, protocols, and reports; support audits and regulatory inspections.
- Support investigations and follow-up for deviations, OOS, and OOT results related to instrumentation.
- Serve as SME for troubleshooting and root cause analysis; coordinate with vendors for repairs/upgrades/service.
- Support evaluation/implementation of new technologies and software; support method transfers from a qualification perspective.
- Lead/support cross-functional projects (lab expansions, new equipment, digital transformation) and continuous improvement.
- Manage change control for instrumentation and systems.
- Maintain records for calibration/maintenance/qualification/deviations; oversee CSV for instruments/software.
- Support configuration/compliance of lab data systems (e.g., Empower, LIMS).
- Train and mentor QC specialists (and QC analysts as requested); share best practices.
Skills/Competencies
- Deep knowledge of IQ/OQ/PQ; strong data integrity and regulatory compliance understanding.
- Troubleshooting/root cause analysis skills.
- Experience with lab software (Empower, LIMS, CDS); Maximo.
- Strong documentation/technical writing; project management/leadership; communication and cross-functional collaboration.
Education/Experience
- QC Specialist III: Bachelor’s in Chemistry + ~3–4 years lab experience, or Master’s + ~2 years.
- QC Specialist IV: Bachelor’s in Chemistry + ~5 years lab experience, or Master’s + ~3 years.
Responsibilities
- Oversee lifecycle management of QC laboratory analytical instrumentation (e.g., HPLC, UPLC, GC, LC-MS, UV-Vis, FTIR, dissolution/TOCs, Particle Counters, MAS-100 Viable Air Sampler).
- Lead installation, qualification, and validation activities (IQ/OQ/PQ) per regulatory guidelines.
- Maintain validated instrument state through calibration, preventive maintenance, and requalification.
- Manage instrument asset tracking and documentation.
- Support risk assessments to ensure instrumentation, software, and data systems comply with data governance and ICH Q9 data integrity principles.
- Develop/review/approve instrumentation SOPs, protocols, and reports; support audits and regulatory inspections.
- Support investigations and follow-up for deviations, OOS, and OOT results related to instrumentation.
- Serve as SME for troubleshooting and root cause analysis; coordinate with vendors for repairs/upgrades/service.
- Support evaluation/implementation of new technologies and software; support method transfers from a qualification perspective.
- Lead/support cross-functional projects (lab expansions, new equipment, digital transformation) and continuous improvement.
- Manage change control for instrumentation and systems.
- Maintain records for calibration/maintenance/qualification/deviations; oversee CSV for instruments/software.
- Support configuration/compliance of lab data systems (e.g., Empower, LIMS).
- Train and mentor QC specialists (and QC analysts as requested); share best practices.
Skills/Competencies
- Deep knowledge of IQ/OQ/PQ; strong data integrity and regulatory compliance understanding.
- Troubleshooting/root cause analysis skills.
- Experience with lab software (Empower, LIMS, CDS); Maximo.
- Strong documentation/technical writing; project management/leadership; communication and cross-functional collaboration.
Education/Experience
- QC Specialist III: Bachelor’s in Chemistry + ~3–4 years lab experience, or Master’s + ~2 years.
- QC Specialist IV: Bachelor’s in Chemistry + ~5 years lab experience, or Master’s + ~3 years.