QC Analyst II (Microbiology)

Title: QC Analyst II - Microbiology

Location: Milford, MA

Duration: 6+ Months

Responsibilities

In accordance with test method SOP's, perform microbiological analyses including Bioburden, Endotoxin, TOC, Conductivity, Nitrates, Appearance testing, Media performance, Growth promotion and Microbial Identifications.
Perform analytical tests as needed such as pH, basic spectrophotometric methods such as A280nm and A550nm, and potency testing.
Perform environmental monitoring of cleanrooms and water system sampling.
Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, Eu. Ph., GLP, GDP, QSR, and CGMP regulations.
Investigate, assess, and troubleshoot assay and/or equipment problems.
Notify QC Manager immediately when a deviation, an aberrant result, or an OOT/OOS result is discovered. Initiate and participate in authoring investigation reports.
Support investigations of deviations and prepare exception documents, utilizing problem solving tools as needed.
Participate in method qualifications, validations, and transfers.
Always maintain sample tracking and integrity until analyses are reviewed.
Prepare and complete change control requests using electronic systems, e.g., Track wise.
Support Lean principles such as 5S throughout daily work activities.
Ensure personal training requirements are met and that training records are current.
Ensure analytical equipment is calibrated and well maintained at all times.
Perform general lab maintenance. Order supplies as needed, store materials as indicated and discard expired materials as per manufacturer or test method recommendations.

Qualifications

Bachelor's Degree in STEM
2+ years of experience in biopharmaceutical Quality Control in a GMP environment with specific experience in microbiological testing and sampling.
Ability to participate in holiday and weekend coverage is required.
Demonstrated experience using relevant QC procedures, specifications, regulations and standards.
Demonstrated competence in use of computer software, including relevant applications such as Microsoft Office and LIMS.