QC Stability Specialist III/IV at Alkermes, Inc. in Wilmington, OH

Overview:

Primary responsibilities for the QC Stability Specialist III/IVare to execute duties to support the stability program for the Quality Control (QC) department in all aspects in compliance with internal SOPs. This individual is capable and possesses the project management skills to track all aspects of annual commitments studies across the site and ensuring FDA required studies are met. This individual is capable and will perform creation of stability protocols and drafting complex (i.e. multiple lot) stability reports. The individual will support all aspects of stability timepoint pulls and sample testing. This individual will track department metrics and department compliance with all aspects of the QC stability program with regard to stability testing, review and initiation. Must demonstrate technical knowledge, be familiar with basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to quality, compliance and scientific excellence. This individual is capable of executing all duties of a Stability Associate.

Responsibilities:

Contribute to the compliant operation of the QC Stability Program.
Communication across multiple groups and sites as this relates to all day to day activities and responsibilities.
Support all aspects of annual commitment studies and all aspects of study identification and placement across the site in order to ensure FDA commitments are met.
Support department wide projects, attending project meetings as the QC Stability Team representative, utilizing SOPs, technical knowledge of health authority guidance documents; project related drafting, reviewing, and approving stability protocols and reports; initiating stability studies, performing stability pulls, and trending data as it related to project management and reporting results for discussion to the project team.
Generation of stability SOPs, creation of original protocols and complex stability reports. Review and update stability protocol, report and SOP revisions as needed.
Support scheduling for the QC department stability program all stability timepoint pulls and scheduling and planning per relevant protocols and stability program SOPs.
Support tracking of all stability metrics and QC department compliance with local and global SOPs as required with regard to testing, review and initiation of stability sample completion.
Maintain stability sample inventory and perform stability sample shipments to contract laboratories and/or sample storage vendors.
Ensure stability chamber organization, maintenance and support troubleshooting and temperature chart data interpretation.
Support plans for all commercial stability study initiations with stability team members, project teams, chemistry and microbiology supervisors and teams.
Collaborate with internal departments and teams to resolve quality issues regarding facility, products manufactured and released.
Ensure proper documentation (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending.
Ensures compliance with cGMP and safety requirements. Participates and leads continuous quality improvements. Participates in quality audits as needed.

Qualifications:

For QC Specialist III: 5 or more years of relevant life science industry experience performing hands on work in a Quality Assurance/Quality Control setting. At least 1 year of stability program experience in GMP regulated laboratory preferred.
For QC Specialist IV: 8 or more years of relevant life science industry experience performing hands on work in a Quality Assurance/Quality Control setting. At least 1 year of stability program experience in GMP regulated laboratory preferred.
Basic knowledge relevant to stability studies, ICH guidelines related to stability, QC methods used for chemistry and microbiological testing.
Experience in writing SOPs, handling QC samples and generating or supporting stability protocols and reports.
Produce results in a fast-paced and team-oriented environment in-order to meet deadlines, and under minimal supervision. Ability to learn quickly with a desire for continual development and improvement.
Experience with SLIM, LIMS, Trackwise, is preferred.

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About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).

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.