QC Analyst I/II - Environmental Monitoring (3rd Shift)
Wilmington, OH 
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Posted 5 days ago
Job Description

Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development ("R&D") center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.

The following position is for Alkermes, Inc.

QC Analyst I - Environmental Monitoring (3rd Shift)

Position Summary

The QC Microbiology Analyst I is responsible for performing functions including environmental monitoring, utilities monitoring, and testing in a facility that manufactures sterile products and tablets in a GMP environment.

Primary Responsibility

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.

Education Requirement

High School diploma

Associate or B.S degree. in a biological science preferred

Years of Experience

High School diploma - Minimum 1+ years of experience working in a manufacturing and/or regulated environment preferred.

Associate or B.S. degree - Some coursework or experience working in a manufacturing and/or regulated environment preferred.

Working Environment/Physical Demands

Ability to work hands-on in a microbiological laboratory and manufacturing environment.

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.

Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required.

Prolonged periods of sitting/standing and occasional periods of repetitive motion.

Steel toe shoes, scrubs, safety glasses and other PPE equipment must be worn based on job being performed.

Makeup and jewelry not permitted for work in classified areas.

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant 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 class protected by 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.

#LI-AH1

Experience Level:
Associate

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
High School or Equivalent
Required Experience
1+ years
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