QC Specialist III/IV

General Description JOB 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 ResponsibilitiesInstrumentation ManagementOversee 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 platformsLead installation, qualification, and validation (IQ/OQ/PQ) activities in compliance with regulatory guidelinesEnsure instruments remain in a validated state through periodic calibration, preventive maintenance, and requalification activitiesManage instrument asset tracking systems and documentation.Compliance & Data IntegritySupport 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 inspectionsSupport Investigations, deviations, out-of-specification (OOS), and out-of-trend (OOT) results associated with instrumentationTechnical Expertise & TroubleshootingMay serve as SME or support the SME for complex instrument troubleshooting, root cause analysis, and resolution of technical issuesCoordinate with vendors for instrument repairs, upgrades, and service contractsSupport the evaluation and implementation of new technologies, software, and analytical tools.Support method transfers from an instrument qualification perspectiveProject LeadershipLead or support cross-functional projects such as lab expansions, new equipment implementation, and digital transformation initiativesDrive continuous improvement initiatives to enhance lab efficiency, reliability, and compliance.Manage change control processes related to instrumentation and systemsDocumentation & Systems ManagementMaintain accurate and complete records for calibration, maintenance, qualification, and deviationsOversee computerized systems validation (CSV) for laboratory instruments and software platformsSupport other groups to ensure proper configuration and compliance of laboratory data systems (e.g., Empower, LIMS).Training & MentorshipTrain and mentor other QC specialists on instrument operation, troubleshooting, and compliance requirementsMay train and mentor QC analysts, as requested Serve as a resource for best practices in laboratory instrumentationSkills/CompetenciesDeep knowledge of instrument qualification and validation (IQ/OQ/PQ)Strong understanding of data integrity and compliance regulationsExcellent troubleshooting and root cause analysis skillsExperience with laboratory software (e.g., Empower, LIMS, CDS systems)Experience with MaximoStrong documentation and technical writing abilitiesProject management and leadership capabilityEffective communication and cross-functional collaborationPERSONAL ATTRIBUTESAbility to work hard and contribute to an enjoyable rapidly changing working environmentProactively achieves results for the best of the organizationWillingness to learn new thingsCommitment to teamworkCommitment to continuous improvement in all areasAbility to focus attention to details and ensure high quality workAbility to work safely; seek out and encourage safe practicesTakes input from others and stimulates open discussionsExcellent communication and documentation skillsEducation/ExperienceQC SPECIALIST IIIBachelors Degree in Chemistry with approx. 3-4 years of laboratory experience orMasters Degree in Chemistry with approx. 2 years of laboratory experienceQC SPECIALIST IVBachelors Degree in Chemistry with approx. 5 years of laboratory experience orMasters Degree in Chemistry with approx. 3 years of laboratory experienceAbout 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.