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QC-Environmental Monitoring Technician

Employer
Just - Evotec Biologics
Location
Redmond, WA
Start date
Jul 29, 2022

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Discipline
Clinical, Clinical Testing/Monitoring, Quality
Required Education
Associate Degree
Position Type
Full time
Hotbed
BioForest

Just is seeking a motivated and creative Environmental Monitoring Technician who desires a significant opportunity to improve worldwide access to biotherapeutics. The EM Technician will join a fast-paced, collaborative, and multidisciplinary Quality Control team. This position will be responsible for routine sampling of facility water samples as well as facility air and surface samples in controlled classified environments, including ISO classified cleanrooms. These efforts support GMP manufacturing activities for biotherapeutic products. As a key member of the QC group, the successful candidate will have excellent aseptic technique, good documentation practices, be an organized thinker, practice strong written and verbal communication skills, multitask effectively and works well independently and collaborative on teams.

Responsibilities:

  • Required to travel to both the Redmond, WA and the Seattle, WA facility, as applicable.
  • Perform process and facility Environmental Monitoring: Active/passive viable air sampling, surface sampling, and airborne particulate monitoring.
  • Collect water samples (city, RO, DI, Milli-Q, WFI, etc.) from various valve locations throughout the facility
  • Ensure the maintenance of the EM equipment is up to date.
  • Maintain metrics and contribute to routine EM trending and trending summary reports.
  • Use Laboratory Information Management System (LIMS) electronic notebooks, as needed
  • Order, inventory, stock supplies, clean lab spaces, ship samples, as needed
  • May perform some microbiological lab support activities (micro plate release, Gram stains, plate reads, etc.) with additional training.
  • Ensure the use of proper aseptic technique during testing of controlled environments and utility systems.
  • Perform all work in compliance with site quality, site safety guidelines.
  • Collaborate with other team members to ensure the quality task is performed in timely manner.
  • Must demonstrate flexibility in adjusting to changing priorities and schedules.
  • Attend mandatory trainings as required by site regulatory requirements and management.
  • Perform investigations, and perform other general duties associated with the position as required by supervision.
  • Collaborate with Quality Assurance, Manufacturing, Material Management, Facilities/Engineering and other functions to ensure internal timelines, sample testing turnaround times and team milestones are achieved
  • Assist in procedure and job aide document revisions
  • Provide support during routine and emergency activities in support of facility repairs, shutdowns, and cleaning activities
  • Help identify gaps, design collaborative solutions and implement laboratory improvements
  • Participate in laboratory investigations, deviations, OOS, and CAPAs

Required Qualifications:

  • Associate Degree (or) completion of four college-level life science courses required.
  • Good interpersonal skills, hands on, analytical, and problem solving and decision-making skills.
  • Excellent communication skills (oral and written) and data management skills
  • Strong adherence to data integrity requirements
  • Good computer skills, including utilizing personal computers and data entry programs.
  • Ability to work independently and with others to accomplish goals and priorities.
  • Must possess effective time management skills, demonstrate initiative, resourcefulness and flexibility to work independently and as part of a team
  • Ability to interact constructively with co-workers
  • Flexibility and teamwork skills, high level of energy and regular, consistent attendance.
  • Good organizational skills with attention to detail
  • Ability to understand analytical/technical data
  • Ability to learn regulatory requirements and guidelines (ICH, CFR, FDA) as they relate to environmental monitoring
  • Must possess good hand-eye coordination.
  • Ability to wear various personal protective equipment (PPE) including full cleanroom gowning in support of ISO-8, ISO7 and ISO-5 workspaces as deemed necessary by EH&S, leadership team, corporate, or safety guidelines.
  • Ability to use various cleaning and disinfectant agents
  • Required to stand or sit for long periods of time while performing duties.
  • Must be able to stand 8+ hours a day.
  • Responsibilities also include the ability to lift heavy objects (up to 50 pounds), kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, and reach without accommodation.
  • Exposure to medium noise levels.

Preferred Qualifications:

  • Previous experience in a microbiology lab, preferred.
  • Experience in a quality control / production environment in a cGMP facility, preferred
  • Experience with implementation of automated platforms, preferred


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