QC Analyst III - Environmental Monitoring

Alkermes • Wilmington, OH

2d • Onsite

About The Position

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.

Requirements

• 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
• Maintains a clean, organized lab environment
• Commitment to teamwork
• Willingness to learn new things
• Commitment to continuous improvement in all areas
• Lead training on environmental monitoring, utilities, gowning, or aseptic practices
• Works closely with manufacturing for training and sample coordination
• Maintain documentation in accordance with GMP including timely recording of information
• 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 being 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

Responsibilities

• Prepare such as change controls, risk assessments, SOP’s, protocols, final reports 20%
• Perform training of manufacturing and EM personnel 20%
• 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 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%

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree