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Job Description
View More Jobs QC Specialist III/IV Wilmington, OH, United States Job Description
GENERAL DESCRIPTION
The Quality Control
QC SPECIALIST III/IV
is responsible for lifecycle management, compliance, and performance of analytical instrumentation used within Quality Control laboratories. This role serves as a technical expert, ensuring instrument qualification, calibration, maintenance, troubleshooting, and data integrity meet regulatory expectations (FDA, ICH, JP).
MAJOR RESPONSIBILITIES
Instrumentation Management Oversee lifecycle management of chemistry or microbiology laboratory instruments, including HPLC, UPLC, GC, LC-MS, UV-Vis, FTIR, dissolution systems, or TOCs, Particle Counters, MAS-100 Viable Air Sampler, respectively, and other analytical platforms Lead installation, qualification, and validation (IQ/OQ/PQ) activities in compliance with regulatory guidelines Ensure instruments remain in a validated state through periodic calibration, preventive maintenance, and requalification activities Manage instrument asset tracking systems and documentation. Compliance & Data Integrity Support Risk assessments to ensure all instrumentation, software, and data systems comply with Alkermes, data governance policy and data integrity principles (ICH Q9) Develop, review, and approve SOPs, protocols, and reports related to instrumentation. Support internal audits, client audits, and regulatory inspections Support Investigations, deviations, out-of-specification (OOS), and out-of-trend (OOT) results associated with instrumentation Technical Expertise & Troubleshooting May serve as SME or support the SME for complex instrument troubleshooting, root cause analysis, and resolution of technical issues Coordinate with vendors for instrument repairs, upgrades, and service contracts Support the evaluation and implementation of new technologies, software, and analytical tools. Support method transfers from an instrument qualification perspective Project Leadership Lead or support cross-functional projects such as lab expansions, new equipment implementation, and digital transformation initiatives Drive continuous improvement initiatives to enhance lab efficiency, reliability, and compliance. Manage change control processes related to instrumentation and systems Documentation & Systems Management Maintain accurate and complete records for calibration, maintenance, qualification, and deviations Oversee computerized systems validation (CSV) for laboratory instruments and software platforms Support other groups to ensure proper configuration and compliance of laboratory data systems (e.g., Empower, LIMS). Training & Mentorship Train and mentor other QC specialists on instrument operation, troubleshooting, and compliance requirements May train and mentor QC analysts, as requested Serve as a resource for best practices in laboratory instrumentation
SKILLS/COMPETENCIES
Deep knowledge of instrument qualification and validation (IQ/OQ/PQ) Strong understanding of data integrity and compliance regulations Excellent troubleshooting and root cause analysis skills Experience with laboratory software (e.g., Empower, LIMS, CDS systems) Experience with Maximo Strong documentation and technical writing abilities Project management and leadership capability Effective communication and cross-functional collaboration
PERSONAL ATTRIBUTES
Ability to work hard and contribute to an enjoyable rapidly changing working environment Proactively achieves results for the best of the organization Willingness to learn new things Commitment to teamwork Commitment to continuous improvement in all areas Ability to focus attention to details and ensure high quality work Ability to work safely; seek out and encourage safe practices Takes input from others and stimulates open discussions Excellent communication and documentation skills
EDUCATION/EXPERIENCE
QC
SPECIALIST III
Bachelors Degree in Chemistry with approx. 3-4 years of laboratory experience or Masters Degree in Chemistry with approx. 2 years of laboratory experience
