GENERAL DESCRIPTION:

The QC Analyst I performs testing of samples submitted to the laboratory in a cGMP compliant manner, as well as according to approved written procedures.  The QC Analyst I may be required to write or revise SOPs, analytical procedures, or other analytical documentation at the discretion of quality control supervisory staff.

Responsibilities

KEY DUTIES:

• Perform testing in accordance with written procedures (i.e. USP/EP/JP grade)
• Documentation of laboratory activities including worksheet/notebook entries according to procedures that define laboratory documentation practices.
• Processing of electronic data using procedures that ensure data integrity and security.
• Ship samples to contract testing facilities.
• Entry of test results from contract laboratories
• Review and countersign (when necessary) logbooks, notebooks, and worksheets for the purpose of verifying compliance with written procedures, good documentation practices, data integrity and accuracy of calculations.
• Transcribe results onto analysis reports.
• Perform daily standardization and performance verifications on laboratory equipment.
• Comply with site-wide procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety, and electronic data security.
• Identify deviations to written procedures.
• Disposal of laboratory waste on an as needed basis.
• Identify and report unsafe conditions within the laboratory.
• Identify OOS results, atypical results, and atypical laboratory events requiring a laboratory investigation; perform investigative testing. 

SKILLS/ABILITIES:

• Ability to perform routine analysis, such as wet chemistry and operate basic laboratory equipment.
• Understands paperwork review process. 
• Ability to follow written procedures and exhibit excellent documentation practices.
• Basic laboratory knowledge and skills
• analytical techniques in wet chemistry/chromatography
• Practical experience with various types of laboratory instrumentation
• Troubleshooting skills with analytical methodology and instrumentation.
• Technical writing skills
• Employee must be able to pass a vision exam prior to employment and annually thereafter. 

PERSONAL ATTRIBUTES:

• Proactively achieves results for the best of the organization.
• Willingness to learn new things.
• Ability to function in a small company atmosphere.
• Ability to cope with a rapidly changing work environment.
• 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
• Responsible for managing their time, organizing their workload to be efficient, and have good organizational and communication skills

Qualifications

EDUCATION AND EXPERIENCE:

• Bachelors Degree in Chemistry with 0-2 years of laboratory experience.  Other fields of specialty in Sciences are also acceptable provided sufficient chemistry coursework is completed.

About Us

Why 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.

VEVRAA Federal Contractor.
We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.