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QC Analyst I - Environmental Monitoring (3rd Shift)

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POST DATE 10/25/2019
END DATE 12/7/2019

Alkermes, Inc. Wilmington, OH

Location
Wilmington, OH
AJE Ref #
585255505
Job Classification
Full Time
Job Type
Regular
Company Ref #
10171
Experience
Entry Level (0 - 2 years)
Education
High School Diploma or GED

JOB DESCRIPTION

QC Analyst I - Environmental Monitoring (3rd Shift)



Position Summary:

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



Major 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.



Qualifications:

* 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

* Pays attention to detail and ensures high quality work

* 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



Education and Experience:

* 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

Working Conditions:

* 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.

* The employee will be required to participate in an on call schedule for various shift, holiday, or weekend work as needed.



Physical Requirements:

* 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



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.

#LI-DB

Experience Level:
Associate

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