Our client, a leader in the pharmaceutical industry, is seeking a QC Environmental Monitoring Associate to join their team.

This job is a fully onsite position - in Bedford, Massachusetts

This job has working hours of Wed-Sat, 730am-6pm

W2 Only

The role involves performing environmental monitoring (EM) at a gene therapy manufacturing facility. Key responsibilities include sampling room and personnel EM, water for injection (WFI), clean steam, and compressed gases.

The job also entails microbial enumeration, LIMS data entry, sample preparation, and assisting with technical issues. Additionally, the ideal candidate will review procedures, improve SOPs, and analyze EM results periodically.

Flexibility in working hours and involvement in deviations, investigations, and CAPA actions may be required.

Responsibilities :

• Perform environmental monitoring (EM) tasks for the aseptic environment, other controlled areas, and plant utility systems following specified instructions and techniques from Standard Operating Procedures (SOP), Training Material, and other GMP documents.
• Incubate and enumerate microbial growth on EM plates.
• Ensure all tasks are completed in a GMP compliant and safe manner.
• Document all tasks within LIMS or standard laboratory paper documentation utilizing GDP principles.
• Entry of information into logbooks as applicable for tasks per SOP.
• Partner and communicate with operations, manufacturing, facilities, and other site departments as required for support of operations and GMP processes.
• Actively participate in daily and weekly laboratory meetings.
• Accurately complete task management tools and handover communications.
• Maintain training for all required tasks.
• May assist in laboratory investigations with limited scope.

Qualifications :

• Bachelor's degree with 0-2 yrs experience, associate degree with 2 years' experience, or High School Diploma or Equivalent (GED) with 4 years' experience.
• Previous environmental monitoring experience
• Good oral, written, and interpersonal communication skills.
• Basic math skills and computer skills such as data entry, along with a high level of attention to detail.
• A demonstrated ability to organize time independently, be able to perform several tasks concurrently (ability to multi-task) and be able to meet objectives in a team-oriented environment.
• Must maintain aseptic qualifications.

Physical Demands / Work Environment / Safety Considerations :

• Stand for extended periods of time with periodic stooping / bending / kneeling.
• Able to lift, push, pull up to 50lbs
• Climb ladders and stairs of various heights.
• Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body.

This requires the ability to change clothes into appropriate gowning and personal protective equipment.

• Must remove all make-up, jewelry, contact lenses, nail polish and / or artificial fingernails while in the manufacturing environment.

Last updated : 2024-06-25