QC Analyst III - Environmental Monitoring

Overview

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.

• Prepare such as change controls, risk assessments, SOPs, protocols, final reports (20%)
• Perform training of manufacturing and environmental monitoring personnel (20%)
• Perform environmental monitoring in aseptic, classified, and controlled areas (routine, batch, quarterly EM). Direct support of the manufacturing schedule may require overtime, weekend or shift work, and holidays (20%)
• Perform utilities monitoring (WFI, CLST, PW, RO, CAIR, NIT, PWTR) and testing (Endotoxin, TOC, Conductivity, Nitrates, Bioburden) (20%)
• Enumerate organisms for environmental monitoring and utility samples (10%)
• Perform basic lab tasks such as hood cleans, autoclave, dry heat oven, lab cleans, etc. (10%)

• Technical writing skills which require minimal guidance from management
• Ability to work hard and contribute to an enjoyable working environment
• Ability to work safely; promote safe practices and aseptic 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
• 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
• Lead training on environmental monitoring, utilities, gowning, or aseptic practices
• Works closely with manufacturing for training and sample coordination
• Able to come up with solutions and resolve minor issues
• Audit support as needed

• EDUCATION:
  
  Bachelors/Associates in Biology (or related field) or high school diploma with additional experience substituted for a degree
• EXPERIENCE:
  
  6 years of cGMP laboratory and/or Pharmaceutical Quality experience. Some college education may be substituted with additional years of relevant work experience.

• The successful employee will function in a microbiological laboratory and manufacturing environment with safe handling of microorganisms; aseptic gowning required with annual requalification
• Employee must be able to pass a vision exam prior to employment and annually thereafter
• On-call schedule for various shift, holiday, or weekend work as needed

• Prolonged periods of sitting or standing
• Occasional repetitive motion
• Walking, lifting, pushing and pulling carts, reaching, climbing, and bending
• Steel toe shoes, scrubs, safety glasses, and other PPE as required
• Makeup and jewelry restrictions in classified areas or as necessary

• Seniority level:
  Mid-Senior level
• Employment type:
  
  Full-time
• Job function:
  Quality Assurance
• Industries: IT Services and IT Consulting