QC Associate II

Job Description

Overview:

The Quality Control Associate II is responsible for sampling and inspecting for quality incoming raw materials such as active pharmaceutical ingredients, excipients, components, and processing aids. This role is also responsible for creating or revising documents in Alkermes' quality systems such as change controls, deviations, supplier non-conformances, standard operating procedures, and specifications.

Responsibilities:

• Review documentation such as Certificate of Analyses, assign expiration and retest dates for incoming raw materials• Coordinate the sampling of all incoming raw materials and components• Collaborate with Supply Chain, Warehouse, Receiving, Quality Assurance, Operations and the testing laboratory in order to schedule activities.• Log samples into Laboratory Information Management System (LIMS), assign testing requirements and enter analytical results• Verify raw material labeling such as part and lot numbers• Inspect containers for defects and damage• Clean sampling equipment and any associated sampling areas• Operation of equipment such as gloveboxes, fume hoods, bio safety cabinets and balances• Perform sampling for all raw materials, active ingredients, excipients, components, processing aids etc.• Follow written procedures for sampling techniques and requirements.• Perform the visual inspection and dimensional testing of components• Operation of equipment such as calipers, tape measure, gauge blocks and sight gauges• Identify non-conforming materials at any point in the process • Coordinate retain program• Prepare and maintain retain samples for raw materials• Receive and maintain finished product retain samples• Plan, schedule and execute periodic retain inspections in compliance with written procedures for both raw materials and finished products• Perform disposals of both raw materials and finished products when appropriate• Write the retain inspection assessment report• Review work of peers, as needed• Create and revise standard operating procedures, technical reports, and specifications, as required • Write supplier non-conformances• Write change controls• Create discrepancy reports and perform Root Cause Analyses• Train other colleagues in methods and procedures• Leads project improvements• Participates in regulatory and internal audits• Works in a safe compliant manner

Required Abilities:

• Able to lift 50lbs
• Able to pass an eye exam for visual inspection
• Able to pass colorblindness exam
• Able to pass health requirements to wear PAPR
• Able to pass class C/D gowning requirements

Preferred Skills/Abilities:

• Ability to comprehend and follow standard operating procedures, strong understanding of cGMP concepts.
• Able to handle multiple projects with competing priorities.
• Intermediate skills in computer use with ability to learn and master new computer applications.
• Self-directed and motivated, detail oriented, quality-minded with strong organizational skills.
• Effective oral and written communication skills
• Able to follow written procedures and exhibit excellent documentation practices.
• Able to take on additional tasks, as required.
• Work well independently or with a group
• Able to work safely; seek out and encourage safe practices
• Use electronic document, inventory and maintenance systems
• LIMS
• SAP
• Veeva
• Microsoft Word
• Microsoft Excel
• Maximo
• PowerPoint
• TrackWise
• EMC ApplicationXtender ((AX) - Scanned Document Library))
• NuGenesis SDMS - Scientific Data Management System

Required Education & Experience:

Bachelor's degree in a scientific discipline with 0-2 years' experience in a quality department

Or

Associate Degree in a scientific discipline with 5+ years' experience in quality department

Or

10+ years' experience in a quality department

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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.