Quality Control Associate

2 weeks ago


Bedford, United States Planet Pharma Full time

Position Summary:

Performs environmental monitoring (EM) for the GMP gene therapy manufacturing facility (GTMF) located in Bedford, MA. Sampling includes room and personnel EM, water for injection (WFI), clean steam, and compressed gases.

Performs microbial enumeration of incubated plates and LIMS data entry and assists in preparing samples for transport. May assist with resolving technical issues, as well as maintenance and cleaning of environmental monitoring equipment and incubators. May review existing procedures and provide technical expertise to improve SOPs and Work Instructions. Responsible for periodic data review and trending of EM results with assistance from area management.

May be required to work periodically during nights/weekends as production schedule dictates (flex hours). May be required to assist with deviations, investigations and CAPA actions.


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.

• Perform general lab tasks including cleaning and equipment preparation.

• Maintain training for all required tasks.

• May assist in laboratory investigations with limited scope.


Requirements:

• 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.

• 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.

• Working in temperature-controlled environments (cold rooms).



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