Sr_-AssociateAssociate-QA-Compliance

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Job Title: Sr. Associate/Associate QA Compliance

Posting Start Date: 8/24/26

Job Description:

Join a Leader in Pharmaceutical Manufacturing - And Build What's Next

As Spokane's Largest Manufacturing Company, Jubilant HollisterStier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world.

We are nationally recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma. Jubilant HollisterStier is proudly part of the global, Jubilant Pharma family. established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world.

For the Builders, Innovators, and Doers - This Is Your Place

If you are someone who thrives on solving complex problems, improving systems, and building real solutions, you'll feel at home here. At Jubilant HollisterStier, your ideas matter - and your impact is felt globally.

Why builders choose us:

• Immediate impact: Your work directly supports essential medicines and allergenic therapies used worldwide.
• Benefits start on day one: Medical, Dental, Vision, FSA/HSA, Life, AD&D, and Disability benefits begin immediately because your well-being shouldn't have a waiting period.
• A career you can grow: We provide opportunities for growth, promotion, and annual raises, with midpoint compensation reserved for high performance and longevity.
• A culture of improvement: We value people who thrive on continuous improvement, innovation, and hands on contribution.
• A stable industry leader: Backed by Jubilant Pharma, we pair long term stability with forward looking innovation.

If you want to build something meaningful with a team that values your drive, skills, and ideas - you belong here.

Job Description:

The QA Compliance Associate provides support to the company Deviations, Corrective and Preventive Action (CAPA) program through a complete assessment of Root Cause Analysis (RCA) of 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 Deviations, CAPA and vendor complaint activities.

• Review Deviations, investigations and CAPAs to ensure accuracy, consistency and compliance with applicable SOPs/Policies, Specifications and related guidelines/regulations.
• Accountable for facilitating Deviations 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. Deviations, 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 Deviations 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.

The QA Compliance Sr. Associate provides support to the company Deviation, Corrective and Preventive Action (CAPA) program through a complete assessment of Root Cause Analysis (RCA) of 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 Deviation, CAPA and vendor complaint activities.

• Lead, facilitate, and conduct deviations, non-conformances investigations.
• Author/draft investigation reports with minimal guidance.
• Ensure timely completion of investigations with accuracy, consistency and compliance with applicable
• SOPs/Policies, Specifications and related guidelines/regulations.
• Interview Subject Matter Experts (SMEs) and involved employee(s) across multiple shifts to investigate
• reported problems and assess the quality impact.
• Conduct investigational meetings with required team member(s) and Verify Investigational findings
• against documented process per SOP.
• Coordinate immediate actions in conjunction with QA and department management upon identification of
• a non-conformance.
• Utilize problem solving techniques and appropriate tools to determine root cause and appropriate causal
• factors.
• Facilitate root cause analysis meetings with key stakeholders to identify solutions for quality
• improvements based on identified trends.
• Work with cross functional team member(s) to develop appropriate CAPA actions.
• Ensure investigations, corrections and CAPA are generated and approved in a timely manner.
• Act as liaison as it relates to specific investigations during client calls and audits.
• Support and/or coordinate data collection required for management reviews, KPI reports, client trend
• review meetings, and all other established regular quality reporting and review mechanisms.
• Communicate/Escalate to management any issues or delays identified during the investigation process.
• Provide investigation training as needed to the Quality Unit and other departments to ensure that
• investigations are handled consistently throughout the company.
• Speak to assigned deviations during regulatory and client audits. 16. Act as the QAC Lead Associate when requested by the QAC SUPERVISOR (in the absence of the QAC Lead Associate)

Qualifications:

QA Associate

• Associates Degree in Biology, Chemistry or related field required.
• 5 years of experience may be used in a lieu of an Associate's degree.
• Bachelor's Degree in a science field desired.
• Sologic Certificate desired.
• Minimum 2 years of experience required. Bachelor's degree can be used in lieu of experience.
• Pharmaceutical and FDA regulated industry experience desired.
• Experience with technical writing, investigations, CAPA systems, building & manufacturing processes/systems, and QC analysis is highly desired.
• Direct or supporting aseptic manufacturing experience in bio/pharma industry desired.
• Microsoft Word & Excel required.
• Knowledge of cGMPs desired.
• Basic exchange of information required.
• Managing conflict and influencing outcomes desired.
• Provides analysis, diagnosis or production tasks which noticeably impact end results.

Sr. QA Associate

• Associates Degree in Biology, Chemistry or related field required.
• 5 years of experience may be used in a lieu

Apply now

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