Regional Manager, Quality Assurance SOFIE
Haverhill, MA20 days ago
- $95,000–$100,000 Per Year
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Skills
- Asepsisunmatched
- Cleaning Equipmentunmatched
- Cleanroomunmatched
- Communication Skillsunmatched
- Computer Skillsunmatched
- Data Entryunmatched
- Detail Orientedunmatched
- Documentationunmatched
- Environmental Monitoringunmatched
- GMP (Good Manufacturing Practices)unmatched
- Gene Therapyunmatched
- High School Diplomaunmatched
- Identify Issuesunmatched
- Interpersonal Skillsunmatched
- Laboratory Information Management System (LIMS)unmatched
- Laboratory Operationsunmatched
- Lift/Move 50 Poundsunmatched
- Manufacturingunmatched
- Manufacturing Operationsunmatched
- Mathematicsunmatched
- Multitaskingunmatched
- Operational Communicationsunmatched
- Operational Supportunmatched
- Operations Processesunmatched
- Production Controlunmatched
- Quality Controlunmatched
- Sample/Specimen Processingunmatched
- Standard Operating Procedures (SOP)unmatched
- Team Playerunmatched
- Water For Injection (WFI)unmatched
- Water Samplingunmatched
- Water Utilityunmatched
- Writing Skillsunmatched
Description
Performs environmental and utility monitoring within the classified cleanroom suites of the GMP Gene Therapy Manufacturing Facility (GTMF) in Bedford, MA.
Responsibilities:
Responsibilities:
- Collection of environmental monitoring (EM) samples for classified manufacturing areas and personnel, as well as utility sampling of Water for Injection (WFI), clean steam, and compressed gases.
- Conducts microbial enumeration of incubated media, documents results in the Laboratory Information Management System (LIMS), and prepares samples for microbial identification and transport.
- Assists with troubleshooting technical issues and performs routine cleaning of environmental monitoring equipment and incubators.
- Performs data entry and peer review of environmental monitoring data following good documentation practices (GDP) principles.
- Provides flexible support for critical manufacturing operations by performing environmental monitoring during active production.
- Hours: Monday through Friday 7:30 AM 4 PM during training period. Once trained, routine schedule is Wednesday through Saturday, 7:00AM- 5PM.
- Core Lab & Ops: This role requires all work to be conducted on-site.
- 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.
- Ability to stand for extended periods with periodic stooping, bending, or kneeling.
- Ability to lift, push, and pull up to 50 lbs.
- Capability to climb ladders and stairs of varying heights.
- Work in a controlled cleanroom environment requiring personal protective equipment (PPE) for head, face, hands, feet, and body.
- Work in temperature-controlled environments, including cold rooms.
- Must remove make-up, jewelry, and contact lenses when working in clean room-associated spaces.
- Bachelors degree with no 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.
Numbers & Facts
| Location | Bedford, MA |
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