QC Analyst - Microbiology (Contract)

JOB SUMMARY

The QC Analyst will be responsible for routine and non-routine QC sampling and testing for the quality of products manufactured for our clients. QC is responsible for execution of the Environmental Monitoring (EM) program in place to monitor Genezen's controlled manufacturing environments (cleanrooms) as well as monitoring of utility systems 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. This role supports daily operations as well as occasional weekend and holiday operations. This may include but is not limited to in-process monitoring and testing, lot release testing, and stability testing.  Supporting activities for quality systems: utility monitoring excursions, non-conformance, deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), and change controls may be required. 

ESSENTIAL JOB FUNCTIONS

• Perform routine/non-routine environmental monitoring of cGMP
• Perform routine/non-routine sampling of utility
• Perform routine/non-routine testing and review of cGMP samples in accordance with Standard Operating Procedures (Bioburden, Endotoxin, TOC, Conductivity, Nitrates, Micro ID).
• Performs peer review with minimal errors.
• Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory of supplies, etc.
• Assist with data trending and aid in compilation of trend
• Support shipment of samples to contract testing laboratories, as required.
• Support of quality systems: utility monitoring excursions, non-conformance, deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), and change controls.
• Maintain QC Microbiology related systems in compliance with industry standards.

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

BA or BS in Microbiology or other related science

ON-THE-JOB EXPERIENCE

Minimum 0-3 years of laboratory base experience within QC testing capacity, preferably in cGMP environment.

Follow procedures trained on and complete documentation applying cGMP/GDP/ALCOA+.

Understanding of industry testing requirements/standards

SKILLS/ABILITIES

Proficiency in computer applications including MS Word, Excel, and LIMS (preferred).

Good/effective communication, organizational, and time management skills with the ability to work well with others and independently

Flexibility and willingness to learn, with a proactive approach to making a positive impact

Detail Oriented

PHYSICAL DEMANDS

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

Work Environment

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to extremely loud noise levels

Movement

• Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; 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 25 pounds
• Occasionally lift and/or move up to 50 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