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.

JOB DESCRIPTION:

The QA Compliance Associate/Sr. 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.
1. Lead, facilitate, and conduct deviations, non-conformances investigations.
2. Author/draft investigation reports with minimal guidance.
3. Ensure timely completion of investigations with accuracy, consistency and compliance with applicable SOPs/Policies, Specifications and related guidelines/regulations.
4. Interview Subject Matter Experts (SMEs) and involved employee(s) across multiple shifts to investigate reported problems and assess the quality impact.
5. Conduct investigational meetings with required team member(s) and Verify Investigational findings against documented process per SOP.
6. Coordinate immediate actions in conjunction with QA and department management upon identification of a non-conformance.
7. Utilize problem solving techniques and appropriate tools to determine root cause and appropriate causal factors.
8. Facilitate root cause analysis meetings with key stakeholders to identify solutions for quality improvements based on identified trends.
9. Work with cross functional team member(s) to develop appropriate CAPA actions.
10. Ensure investigations, corrections and CAPA are generated and approved in a timely manner.
11. Act as liaison as it relates to specific investigations during client calls and audits.
12. 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.
13. Communicate/Escalate to management any issues or delays identified during the investigation process.
10. Special assignments as directed by the supervisor.

QUALIFICATIONS:

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
• 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.
• Knowledge of cGMPs desired.
• Microsoft Word & Excel required.
• Basic exchange of information required.
• Managing conflict and influencing outcomes desired.
• Provides analysis, diagnosis or production tasks which noticeably impact end results.

Sr. Associate:

• Associates Degree in Biology, Chemistry or related field required.
• Minimum of 5 years related experience required with an Associate’s Degree.
• Minimum of 2 years related experience required with a Bachelor degree.
• Pharmaceutical and FDA Regulated Experience required.
• Microsoft Word/ Excel and knowledge of cGMPs required.
• Experience with technical writing, investigations, CAPA system, building and manufacturing
• processes/systems, QA operations systems, and QC analysis is required.
• Must have ability to prioritize investigations based on impact to the facility and release of batches.
• Bachelor’s Degree in a science field desired.
• Direct or supporting aseptic manufacturing experience in bio/pharma industry desired.

Shift: Weekday Days – 0800 - 1630

• Medical, Dental, Vision, Flexible Spending and Health Savings Accounts
• Life, AD&D, Short and Long Term Disability
• 401(k) with company match
• Generous paid time off pla