QC Analyst I/II

Job Description

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.

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
• 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

EDUCATION & EXPERIENCE

• Level I: High school diploma - Some experience in a GMP lab environment
• Level II: High school diploma with minimum 2 years' experience in a GMP lab environment
• Associate's or Bachelor's Degree in a biological science field. 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.
• 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.

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

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About Us

Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

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.