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
QC SPECIALIST IV
- Bachelors Degree in Chemistry with approx. 5 years of laboratory experience or
Masters Degree in Chemistry with approx. 3 years of laboratory experience
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About UsWhy join Team Alkermes?
Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.
We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
Skills Required
- Bachelor's Degree in Chemistry
- Master's Degree in Chemistry (alternative qualification)
- 3-5+ years of laboratory experience (3-4 years for QC III; ~5 years for QC IV)
- Experience with HPLC, UPLC, GC, LC-MS, UV-Vis, FTIR, dissolution systems, TOC, particle counters, MAS-100
- Instrument qualification and validation (IQ/OQ/PQ)
- Knowledge of data integrity and regulatory requirements (FDA, ICH, JP, ICH Q9)
- Experience with laboratory software (Empower, LIMS, CDS systems)
- Experience with Maximo
- Computerized systems validation (CSV) experience
- Troubleshooting and root cause analysis for complex instruments
- Support for audits, investigations, deviations, OOS/OOT
- Project leadership and change control management experience
- Strong documentation and technical writing skills
What We Do
Alkermes focuses on the development of innovative medicines that seek to address unmet needs of people living with serious mental illness, addiction, and cancer. As a fully-integrated, global biopharmaceutical company, we apply our scientific expertise and proprietary technologies to develop products that are designed to make a meaningful difference in the way patients manage their disease. We are inspired by some of the most pressing public health challenges of our time to help advance innovation with the potential to improve treatment options and outcomes for patients. Beyond our important mission of developing medicines, we believe it is our responsibility to take a holistic approach as we seek to support patients, caregivers, and broader impacted communities. In this context we also work to help support and enhance the systems through which these complex diseases are treated. We are committed to patient engagement, disease education and awareness, and advocacy for important policies that support equitable access to quality treatment. Headquartered in Dublin, Ireland, we have an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. See our Community Guidelines: https://www.alkermes.com/social-community-guidelines
