Alkermes · 1 month ago
Temp-QC Analyst EM-1st Shift
Alkermes is a global biopharmaceutical company dedicated to developing medicines for complex psychiatric and neurological disorders. The Temp QC Analyst will be responsible for environmental and utilities monitoring in a GMP environment, ensuring compliance and supporting the manufacturing schedule.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Perform environmental monitoring in aseptic, classified, and controlled areas (routine, batch, quarterly EM). Direct support of the manufacturing schedule will be required, which may include over time, weekend or shift work, and holidays
Perform utilities monitoring (WFI, CLST, PW, RO, CAIR, NIT, PWTR) and testing (Endotoxin, TOC, Conductivity, Nitrates, Bioburden)
Enumerate organisms on cultured media for environmental monitoring and utility samples
Review of routine paperwork
Perform basic lab tasks such as hood cleans, autoclave, dry heat oven, lab cleans etc
Qualification
Required
Ability to work hard and contribute to an enjoyable working environment
Ability to work safely; seek out and encourage safe practices Gowning in an aseptic environment
Self-starter that takes initiative to perform work with minimal supervision
Maintain documentation in accordance with GMP including timely recording of information
Ability to cope with a rapidly changing work environment
Maintains a clean, organized lab environment
Commitment to teamwork
Willingness to learn new things
Commitment to continuous improvement in all areas
Effective communication with co-workers and supervisors
Pays attention to detail and ensures high quality work
High School diploma, Associate or Bachelor Degree in a biological science
High School diploma with some experience in a GMP lab environment or Bachelor or Associate Degree in a biological science
Some college education may be substituted with additional years of relevant work experience
The successful employee will have the ability to function in a microbiological laboratory and manufacturing environment
The employee should have no inhibitions regarding safely handling microorganisms present in the laboratory and no health conditions/allergies that would prevent them from doing so or conditions which would prevent them from aseptically gowning
Aseptic gowning must be able to be maintained including an annual requalification
Employee must be able to pass a vision exam prior to employment and annually thereafter
The employee will be required to participate in an on call schedule for various shift, holiday, or weekend work as needed
Prolonged periods of sitting or standing
Occasional periods of repetitive motion
Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required
Steel toe shoes, scrubs, safety glasses, and other PPE equipment must be worn based on job being performed
Makeup and Jewelry will not be permitted for work in classified areas or other areas as necessary
Benefits
Health Insurance
Company
Alkermes
Alkermes is a biotechnology company that develops, manufactures and commercializes medicines for the treatment of chronic diseases.
H1B Sponsorship
Alkermes has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (32)
2024 (20)
2023 (21)
2022 (14)
2021 (27)
2020 (22)
Funding
Current Stage
Public CompanyTotal Funding
$250MKey Investors
Primecap Management
2017-11-20Post Ipo Equity
2014-01-13Post Ipo Equity· $250M
2011-09-16IPO
Recent News
2026-01-13
2026-01-09
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