QC Analyst III - Environmental Monitoring

Responsibilities:
- Prepare change controls, risk assessments, SOPs, protocols, and final reports.
- Perform training for manufacturing and environmental monitoring (EM) personnel.
- Conduct environmental monitoring in aseptic, classified, and controlled areas (routine, batch, quarterly EM) in support of manufacturing schedule (may include overtime/weekends/shifts/holidays).
- Perform utilities monitoring (WFI, CLST, PW, RO, CAIR, NIT, PWTR) and testing (endotoxin, TOC, conductivity, nitrates, bioburden).
- Enumerate organisms for environmental monitoring and utility samples.
- Perform basic lab tasks (hood cleans, autoclave, dry heat oven, lab cleans).

Qualifications:
- Technical writing skills with minimal management guidance.
- GMP documentation with timely recording; attention to detail and high-quality work.
- Safe aseptic gowning practices; self-starter with minimal supervision; teamwork; willingness to learn and continuous improvement.
- Lead training on environmental monitoring, utilities, gowning, or aseptic practices; work closely with manufacturing.

Education/Experience:
- Bachelor’s/Associates in Biology (or related) OR high school diploma with equivalent experience.
- 6 years of cGMP laboratory and/or Pharmaceutical Quality experience.

Working Conditions:
- Ability to handle microorganisms; maintain aseptic gowning with annual requalification; pass vision exam annually; on-call schedule for shifts/weekends/holidays as needed.

Physical Requirements:
- Prolonged sitting/standing; walking/lifting/carts/reaching/climbing/bending; wear required PPE; no makeup/jewelry in classified areas.