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Jubilant HollisterStier 35410 EM Specialist Weekend Days in Spokane, Washington

Jubilant HollisterStier LLC, a well-established member of the business community in Spokane, Washington, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. Jubilant HollisterStier is a proud member of the Jubilant Pharma family.

 

Our Promise:  Caring, Sharing, Growing

We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources.

Job Description:

The Environmental Monitoring department performs the functions associated with sampling, initiating tests, collecting and evaluating test results related to defined quality parameters for surface, air, personnel, product and utility systems such as compressed gases and WFI. The Specialist oversees EM functions and personnel, schedules tasks and personnel, assists in training EM Technicians and gown training of all aseptic personnel.

Essential responsibilities include but are not limited to:

  • Attain and maintain Aseptic Gown Certification
  • Collect and test samples and data within an aseptic environment and systems over extended periods of time (8-10 hours/day, with appropriate breaks).
  • Operate appropriate monitoring sampling and testing equipment.
  • Prepare and autoclave supplies required for collecting and testing samples.
  • Enter and verify data and electronic spreadsheets for accuracy.
  • Write clear, concise observational memos.
  • Read, understand and review SOPs as required.
  • Read results of testing and review and trend environmental data.
  • Schedule EM personnel/tasks.
  • Train or schedule training for EM personnel and gown certification for aseptic entry.
  • Review HEPA filter records.
  • Issue QAMs, NCMRs, Action and Alert notices, perform related investigations and prepare required reports.
  • Write and review SOPs and protocols as needed.
  • Provide back up for EM supervisor and EM issues as required.

Qualifications:

  • Required: Bachelor degree with a major in Microbiology, Medical Technology or related science and 1 year pharmaceutical or environmental monitoring experience, preferably in a lead position --OR- an Associate Degree or greater with a major in Microbiology, Medical Technology or related science and 2 years pharmaceutical or lab experience, preferably in a lead position --OR- approximately 3 years experience as a Environmental Monitoring Technician.
  • Pharmaceutical and laboratory experience required.
  • Lead and FDA Regulated Industry experience desired.
  • Proficiency in MS Word and Excel required. Experience using PowerPoint desired.
  • Mechanical Aptitude and Manual Dexterity required.
  • Must be able to read and understand SOPs, write clear and accurate memos, and understand aseptic processing concepts.
  • Clear communication skills, manage conflict and influence outcomes, tact, basic exchange of information.
  • Must have a working knowledge of cGMP, appropriate CFRs, and guidelines.
  • Must be able to attain and maintain gown certification.
  • Physical Requirements:
  • Corrected Near-Point Vision, Ability to lift up to 25 lbs unassisted, Exposure to Allergens, Working in Aseptic Areas, Working in Confined Spaces, Repetitive Activity, Noises, Pushing, Pulling, Twisting, and prolonged Sitting and Standing.

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Shift: Weeke

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