DescriptionPOSITION 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, SOP’s, 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
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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