QC Specialist III/IV

Alkermes•Wilmington, OH

2d•Onsite

About The Position

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).

Requirements

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
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

Responsibilities

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.
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
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
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
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).
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