QC Analyst III/IV - Environmental Monitoring

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

Major Responsibilities

Percentage of time spent on each responsibility

Prepare documents such as change controls, risk assessments, SOPs, protocols, final reports and support of discrepancies

35%

Review of risk assessments, deviations, protocols, change controls, and other technical documents from internal and external departments

20%

Perform training of manufacturing and EM personnel

15%

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

10%

Perform utilities monitoring (WFI, CLST, PW, RO, CAIR, NIT, PWTR) and testing (Endotoxin, TOC, Conductivity, Nitrates, Bioburden)

10%

Enumerate organisms for environmental monitoring and utility samples.

5%

Perform classified area walkthroughs and production observations

5%

QUALIFICATIONS

• Technical writing skills which require minimal guidance from management

• 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

• Commitment to teamwork

• Willingness to learn new things

• Commitment to continuous improvement in all areas

• Effective communication with co-workers, other departments, and management

• Lead training on environmental monitoring, utilities, gowning, or aseptic practices

• Works closely with manufacturing for training, walkthroughs, and sample coordination

• Able to come up with solutions and resolve issues

• Audit support as needed

• Act as department representative in meetings

EDUCATION: Bachelors/Associates in Biology (or related field) or high school diploma with additional experience being substituted for a degree

EXPERIENCE: QC Analyst III - 6+ years of cGMP laboratory and/or Pharmaceutical Quality experience. Some college education may be substituted with additional years of relevant work experience.

QC Analyst IV - 8+ years of cGMP laboratory and/or Pharmaceutical Quality experience. 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

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.

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