Temp-QC Analyst

About the role

The QC Analyst I performs testing of samples submitted to the laboratory in a cGMP-compliant manner, following approved written procedures. The role may also involve writing or revising SOPs, analytical procedures, or other documentation at the discretion of quality control supervisory staff.

Responsibilities

• Perform testing in accordance with written procedures (e.g., USP/EP/JP grade).
• Document laboratory activities, including worksheet/notebook entries, following procedures that define laboratory documentation practices.
• Process electronic data using procedures that ensure data integrity and security.
• Ship samples to contract testing facilities and enter test results from contract laboratories.
• Review and countersign (when necessary) logbooks, notebooks, and worksheets to verify 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 change control, documentation, deviation reporting, cGMP compliance, safety, and electronic data security.
• Identify deviations to written procedures.
• Dispose of laboratory waste as needed.
• Identify and report unsafe conditions within the laboratory.
• Identify out-of-specification (OOS) results, atypical results, and atypical laboratory events requiring investigation; perform investigative testing.

Skills

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

Personal Attributes

• Proactively achieves results for 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 and continuous improvement.
• Attention to detail and focus on high-quality work.
• Ability to work safely and encourage safe practices.
• Strong time management, organizational, and communication skills.

Requirements

Bachelor’s Degree in Chemistry with 0–2 years of laboratory experience. Other scientific fields are acceptable provided sufficient chemistry coursework is completed.

About Us

Alkermes applies its decades of deep neuroscience expertise to develop medicines for people living with complex psychiatric and neurological disorders. A global biopharmaceutical company headquartered in Ireland with U.S. locations in Massachusetts and Ohio, Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder, and narcolepsy, as well as a pipeline of clinical and preclinical candidates.

Alkermes has been recognized as an employer of choice, certified as a Great Place to Work in the U.S. (2024 and 2025), 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 a Best Place to Work in BioPharma by Fortune Magazine.