QC Biologist II

Position Description, Functions, Duties and Tasks:

• Develops, reviews and approves SOPs, analytical data, and action limit reports.
• Reviews and approves release of product and in-process results through SAP or other controlled system.
• Prepares system trend reports utilizing statistical process control.
• Participates in quality audits as needed.
• Identifies and coordinates qualification of contract testing laboratories at the direction of the QC Manager.
• Assists in coordinating FDA inspections and responses to FDA-483 observations.
• Product testing (Bioburden testing, Sterility testing, and Endotoxin testing)
• Bioprocess support (Fermentation, Isolation, and Purification) (Pre-inoculation bioburden, Inprocessfermentation, and In-process and final bioburden screening)
• Laboratory maintenance (Stock culture maintenance, Media performance testing, Equipment maintenance and calibration, Data and records maintenance, and Procedure and method reviews)
• Assists in the maintenance of laboratory requirements, including reagents and supplies.
• Performs all activities in a safe and conscientious manner. Maintains a clean environment and assists with periodic lab clean-ups, and moving of equipment and laboratory supplies.
• Environmental monitoring of Clean Room areas [Non-viable air monitoring (includesbiohoods, aseptic filling areas, and isolators), Viable air monitoring (includes biohoods, aseptic filling areas, and isolators), and Viable surface monitoring (includes biohoods, aseptic filling areas, and isolators)]
• Biocontainment monitoring (Fermentation, Purification, and Isolation) (Viable air monitoring,viable surface monitoring, and phage monitoring)
• Assists with training of Microbiology personnel as required.

• Education:
  • B.S. Degree in Microbiology or other Biological Science required.
• Experience:
  • Familiar with current industry standards for testing.
• Required Skills:
  • Basic computer skills (Word and Excel) required.

• Experience:
  • Three (3) to four (4) years experience in the pharmaceutical industry strongly preferred, with experience in aseptic operations highly desired.
  • Experience as a Laboratory Microbiologist strongly preferred.

• Familiarity with data systems (SAP, etc.) a plus.
• Understanding of cGMP and other regulatory standards for Finished Pharmaceuticals and Active Pharmaceutical Ingredients (API).
• Excellent communication, organization and problem solving skills.
• Strong interpersonal and team building skills; desire and ability to work in a team environment.
• Must be able to follow detailed instructions as well as work in safe and responsible manner.
• Must be able to function responsibly and independently.
• Must handle chemicals and biohazardous materials.