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Specialist, QA Oversight Weekend Swing

Jubilant HollisterStier Spokane

This is a Full-time position in Spokane, WA posted September 1, 2021.

Jubilant HollisterStier LLC 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 owned by Jubilant Life Sciences.

The QA Oversight Associate provides support to all functions associated with manufacturing and quality control operations via daily on-the-floor support. The oversight includes evaluation and review of ongoing Manufacturing and Quality Control Operations, and management of all Quality functions related to facility, systems, and manufacturing support. Other areas include (but are not limited to) Metrology, Engineering, Maintenance, and Information Systems (IS). Essential responsibilities include but are not limited to:

  • Ensure that all applicable US and European regulatory requirements are being met within the procedures and practices of the Manufacturing and Quality Control units.
  • Conduct on the floor oversight of the Manufacturing and QC facilities to ensure that all products produced meet labeling, dating, and packaging requirements as defined by Standard Operating Procedures (SOP’s) and current Good Manufacturing Practices (cGMP).
  • Provide necessary daily, weekly and monthly summaries and reviews for on the floor observations, provide responses to observations and ensure that all corrective action measures are completed as described and within the timeframe given in the response.
  • Recognize potential problems and review and approve proposed mitigations, or document problems encountered, collaborating with department supervisors to ensure that quality requirements are clearly communicated to resolve any deficiencies in product quality or manufacturing systems and procedures.
  • Ensure that investigations related to deviations in facility or support systems are complete and adequate.
  • Position requires the ability to solve complex problems independently and within a team environment.
  • QA oversight of aseptic processing.
  • Assist in training of any new QA Oversight personnel.

Qualifications:

  • Bachelors of Science Degree in a scientific discipline (or 4 years of technical manufacturing experience in lieu of degree) required.
  • Minimum of 2 years related experience enforcing compliance in regulated industry required or 3 years direct pharmaceutical experience in lieu of.
  • FDA Regulated Industry required.
  • Proficiency in Microsoft Word, Excel and PowerPoint required.
  • Mechanical Aptitude desired.
  • In-depth understanding of the relationship between regulatory requirements, operating procedures, and ensuring compliance in a production environment.
  • Excellent interpersonal skills required. Interaction with departments and inspectors/auditors from regulatory agencies and customer companies.
  • Physical Requirements: Exposure to allergens, working in aseptic areas, prolonged standing and sitting. Minimum travel required.

Jubilant HollisterStier is a great place to grow!

If you’re up for a rewarding challenge, we invite you to take the first step and apply today!

https://www.jubilantcareers.jubl.com

Jubilant HollisterStier is an EEO/AA Employer.

All qualified applicants will receive consideration for employment without regard to their protected veteran status and will not be discriminated against on the basis of disability.

If you require assistance applying for a position, please contact our HR Department at:

HResources@jhs.jubl.com

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