QC Analyst III/IV - Environmental Monitoring
Alkermes
12 days ago
On-site
Cincinnati Metropolitan Area
Operations
QC Microbiology Analyst responsibilities in a GMP facility manufacturing sterile products and tablets, including environmental monitoring, utilities monitoring, and testing.
Major Responsibilities:
- Prepare documents such as change controls, risk assessments, SOPs, protocols, final reports, and support of discrepancies. (35%)
- Review risk assessments, deviations, protocols, change controls, and other technical documents from internal/external departments. (20%)
- Train manufacturing and EM personnel. (15%)
- Perform environmental monitoring in aseptic, classified, and controlled areas (routine, batch, quarterly EM), with required support to the manufacturing schedule including possible overtime, weekends/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 with minimal guidance.
- Ability to work safely; encourage safe practices.
- Gowning in an aseptic environment.
- Self-starter; initiative with minimal supervision.
- Maintain GMP documentation with timely recording.
- Attention to detail; high-quality work.
- Ability to cope with rapidly changing environment.
- Teamwork, continuous improvement, willingness to learn.
- Effective communication with coworkers, other departments, and management.
- Lead training on environmental monitoring, utilities, gowning, or aseptic practices; work with manufacturing on training, walkthroughs, and sample coordination.
- Ability to solve issues; audit support as needed.
- Act as department representative in meetings.
Education:
- Bachelor’s/Associate’s in Biology (or related) or high school diploma with additional experience.
Experience:
- QC Analyst III: 6+ years cGMP laboratory and/or Pharmaceutical Quality experience (some college may substitute).
- QC Analyst IV: 8+ years cGMP laboratory and/or Pharmaceutical Quality experience (some college may substitute).
Major Responsibilities:
- Prepare documents such as change controls, risk assessments, SOPs, protocols, final reports, and support of discrepancies. (35%)
- Review risk assessments, deviations, protocols, change controls, and other technical documents from internal/external departments. (20%)
- Train manufacturing and EM personnel. (15%)
- Perform environmental monitoring in aseptic, classified, and controlled areas (routine, batch, quarterly EM), with required support to the manufacturing schedule including possible overtime, weekends/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 with minimal guidance.
- Ability to work safely; encourage safe practices.
- Gowning in an aseptic environment.
- Self-starter; initiative with minimal supervision.
- Maintain GMP documentation with timely recording.
- Attention to detail; high-quality work.
- Ability to cope with rapidly changing environment.
- Teamwork, continuous improvement, willingness to learn.
- Effective communication with coworkers, other departments, and management.
- Lead training on environmental monitoring, utilities, gowning, or aseptic practices; work with manufacturing on training, walkthroughs, and sample coordination.
- Ability to solve issues; audit support as needed.
- Act as department representative in meetings.
Education:
- Bachelor’s/Associate’s in Biology (or related) or high school diploma with additional experience.
Experience:
- QC Analyst III: 6+ years cGMP laboratory and/or Pharmaceutical Quality experience (some college may substitute).
- QC Analyst IV: 8+ years cGMP laboratory and/or Pharmaceutical Quality experience (some college may substitute).