QC Analyst - Microbiology

JOB SUMMARY

The QC Analyst contractor will be responsible for routine and non-routine QC sampling and testing of controlled environments, critical utility systems, and production processes operating in a GMP laboratory. This position works a first shift, 12-hour schedule, Friday-Sunday, 6am-6:30pm fully on-site schedule with occasional holiday support required.

QC Microbiology is responsible for the Environmental Monitoring (EM) program as well as utility monitoring programs, including Water for Injection (WFI), Pure Steam, Purified Water, Compressed Air and Gas systems. These activities are all performed in accordance with cGMP guidelines and are supported by departmental and inter­departmental policies and standard operating procedures (SOPs). 

This position is based at Genezen’s state-of-the-art facility in Lexington, MA. The role supports routine operations of a 7-day production schedule. This may include but is not limited to in-process monitoring and testing activities for utility, intermediates, raw materials and drug product samples. The role also supports quality management systems, including; utility monitoring excursions, non-conformance, deviation investigations, corrective and preventive actions (CAPAs),  Out of Specifications (OOS), and change controls, as required.

ESSENTIAL JOB FUNCTIONS 

• Perform QC testing of in-process and product samples while adhering to standard operating procedures (SOPs).
• Ensure routine QC Environmental Monitoring and Microbiology sampling/testing such as bioburden, endotoxin, growth promotion, Gram stain, and microbial identifications, are performed in compliance with all industry regulations and standards.
• Write, revise, or review SOPs for quality control operations to assure regulatory requirements and industry standards are met.
• Support aseptic processing activities.
• Complete documentation, perform data entry and review in accordance with Good Manufacturing Practices (cGMP) applying ALCOA+
• Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory of supplies, etc.
• Sampling and testing of critical utility systems including water and gas supplied to manufacturing areas.
• Perform data trending and aid in compilation of trend reports.
• Prepare samples for shipment to contract testing laboratories and review of testing data reports, as required.
• Conduct non-conformance and Out of Specification and laboratory investigations and environmental monitoring excursion investigations
• Troubleshooting equipment and microbiological testing methods.
• Training of other Analysts within the department within scope of knowledge.
•  Support internal and cross-functional project related activities as needed.

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs.
• Work outside of normal business hours, including nights, weekends and holidays, when necessary.
• Criminal background check required (completion by staffing agency satisfies this requirement).
• Other duties as assigned.

KNOWLEDGE, SKILLS AND EXPERIENCE

PHYSICAL DEMANDS 

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Rarely lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail