QC Analyst I - Sample Management - Genezen

JOB SUMMARY

The QC Sample Management Analyst I plays a critical role in supporting day-to-day quality operations within the cGMP QC laboratories. This role is responsible for overseeing all aspects of sample management, including the receipt, processing, storage, and retrieval of samples. The analyst will ensure compliance with documentation practices and contribute to maintaining an organized and efficient laboratory environment. This position is based at our state-of-the-art facility in Lexington, MA.

ESSENTIAL JOB FUNCTIONS

• Sample Management:
  • Ensure that all Manufacturing (MFG) and Pilot Plant samples received are accompanied by proper documentation, maintaining data integrity.
  • Dispense samples into aliquots and label them according to QC procedures.
  • Keep storage units accurately inventoried and organized.
  • Ensure all samples transferred in and out of storage units are correctly documented, adhering to good documentation practices (GDP).
  • Alert Quality Control management and project teams about samples received for protocols in the lab.
• Documentation and Compliance:
  • Organize and archive forms as needed, including scanning and filing documents.
  • Author and revise standard operating procedures (SOPs) as required.
  • Prepare release documentation for review and ensure compliance with assigned training.
  • Support internal and external audits as needed.
• Laboratory Support:
  • Perform general housekeeping tasks, monitor and maintain laboratory equipment, and manage inventory of supplies.
  • Prepare shipments for external testing and support continuous improvement initiatives to streamline lab processes.
• Additional Responsibilities:
  • Support data packet reconciliation and archival
  • Perform other related duties as assigned by the supervisor or QC management.

SPECIAL JOB REQUIREMENTS

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

• 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