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, Inprocess fermentation, 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 (includes biohoods, 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.

 

Minimum Qualification (Education, Experience and/or Training, Required Certifications):
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.

 

Additional Preferences:

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.

 

Other Qualifications:
• 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