QC Analyst I/II - Microbiology

Norwood, MA

Job ID: 555

Job Req code: 555

Category: Quality Systems

Job Type: Quality Systems

The QC Analyst I/II performs quality activities in support of product production and releases.  The position has interaction with other internal departments, including Quality Assurance, Validation, Calibration, Materials, and Logistics.  The position also has interactions with external entities including contractors and suppliers. The QC Analyst I/II performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting testing, and reporting results.

Key Responsibilities:

Perform raw material, intermediate and non-routine testing.
Perform routine sampling of clean utilities
Perform and read environmental, personnel, and in-process sterility testing.
Prepare and send out samples for microbiological identification and/or mycoplasma testing.
Perform visual inspection of final product.
Support data entry and generate trend reports as they relate to quality testing.
Revise SOPs.
Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood.
Generate deviation reports, out-of-specification reports and non-routine investigations.
Assist in cross-functional activities to support release of final product
Supports routine laboratory maintenance (e.g. stocking, cleaning, receiving samples)
 
This position requires a minimum of 25 hours/week gowned in classified areas; Class 100, 100K, 10K. This position requires 2-3 hours of standing per day with frequent stooping and lifting. This position also requires use of repetitive hand movement e.g. micropippetting and keyboard use for moderate or long periods of time.

Requirements

Preferred Education and Experience:

Level I: Requires a Bachelor’s Degree or equivalent, with a minimum of 6 months -1 year of related experience in a GMP/Medical Device/ Pharmaceutical or Biological regulated environment.  Degree in Microbiology or related field required.

Level II:  Requires a Bachelor’s Degree or equivalent, with 2-3 years of Microbiology experience in a GMP/Medical Device/ Pharmaceutical or Biological regulated environment.  Degree in Microbiology or related field required.