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Associate, QA Commercial

Jubilant HollisterStier Spokane

This is a Full-time position in Spokane, WA posted November 20, 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 Commercial Associate/ Sr. Associate provides support to the company Incident (Deviation), Corrective and Preventive Action (CAPA) program through a complete assessment of Root Cause Analysis (RCA) of incidents/deviations and vendor complaints/issues. Assure product compliance and product safety. Ensure accurate and timely data entry and oversight of the company Quality Systems related to Incident, CAPA and vendor complaint activities. Essential responsibilities include but are not limited to:

  • Review incidents, investigations and CAPAs to ensure accuracy, consistency and compliance with applicable SOPs/Policies, Specifications and related guidelines/regulations.
  • Accountable for facilitating incident investigation/resolution, assessing product impact and for completing/writing final assessment/lot disposition for QA Management and Client review and approval.
  • Enters data into database in support of the corporate RCA and CAPA activities.
  • Provide oversight of investigational RCA group activities including preparation of meeting agenda, providing necessary information to meeting participants, publishing of meeting minutes, and follow-up on agreed upon activities and tasks.
  • Interface with management and responsible individuals to assure task completion on or before established due dates.
  • Responsible for supporting quality systems, processes and procedures (e.g. Incident, CAPA, Vendor complaint, etc…) to assure compliance and product quality and safety.
  • Accountable for assisting the QA and applicable Department Management to ensure and follow up on implementation of corrective actions that stem from deviations, audit or regulatory inspections.
  • Provide incident and CAPA metrics as needed in support of management review of system data.
  • Work extensively with appropriate department(s) to gain an understanding of the production/analytical testing process and other applicable process to ensure capture of appropriate details and conclusions in the investigation or corrective action documents.
  • Provide investigation training to the Quality Unit and other departments to ensure that investigations are handled consistently throughout the company.
  • Other tasks as directed by the department Supervisor or Manager.

Sr. Associate responsibilities in addition to above.

  • Perform Specifications review and approval
  • Perform SOP revision within the EDMS system

Qualifications:

  • Associates Degree in Biology, Chemistry or related field OR 5 years of experience in lieu of degree required for an Associate. For a Sr. Associate Associates Degree in Biology, Chemistry or related field OR 7 years of experience in lieu of degree is required. Bachelor of Science degree desired.
  • Minimum of 3 years related experience is required for an Associate or 7 years’ experience required for a Sr. Associate. Bachelor’s Degree can be used in lieu of experience.
  • Pharmaceutical and FDA Regulated Industry experience desired.
  • Experience with technical writing, investigation, CAPA systems, building & manufacturing processes/systems, knowledge of cGMPs, and QC analysis is highly desired.
  • Proficiency in Microsoft Word and Excel required.
  • Physical Requirements: Lift up to 30 lbs unassisted. Prolonged sitting

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.jubilantcareer.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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