Sr. Associate, QA Compliance

Xtalks; Spokane (WA); On-site; USD 82,000 - 131,000; Full time

Benefits offered by this job

Medical, Dental & Vision coverage

FSA/HSAs

Life & AD&D Insurance

Short-Term & Long-Term Disability

Employee Assistance Program

Job summary

Jubilant HollisterStier LLC in Spokane, WA, is seeking a QA Compliance Associate to support the Deviation, CAPA and RCA processes, ensuring product compliance and timely data entry within Quality Systems.

You will lead investigations, draft reports, coordinate CAPA actions, and support client audits with cross-functional teams on-site. Strong pharma/regulatory background is required; starting wage range is $81,800–$130,900.

Qualifications

• Associate’s degree in biology, chemistry or related field required.
• Bachelor’s degree in a science field desired.
• Minimum of 5 years related experience required with an Associate’s Degree.
• Minimum of 2 years related experience required with a Bachelor’s degree.
• Pharmaceutical and FDA Regulated Experience required.
• Experience with technical writing, investigations, CAPA system, building and manufacturing processes/systems, QA operations systems, and QC analysis is required.
• Microsoft Word & Excel required. Knowledge of cGMPs required.

Responsibilities

• 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)

Skills

Microsoft Word

Microsoft Excel

Technical writing

Investigations

CAPA system

Education

Associate’s degree in biology, chemistry or related field

Bachelor’s degree in a science field

Tools

CAPA system

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 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)

Required

• Associate’s degree in biology, Chemistry or related field required.
• Bachelor’s degree in a science field desired.
• Minimum of 5 years related experience required with an Associate’s Degree.
• Minimum of 2 years related experience required with a Bachelor’s degree.
• Pharmaceutical and FDA Regulated Experience required.
• Experience with technical writing, investigations, CAPA system, building and manufacturing processes/systems, QA operations systems, and QC analysis is required.
• Microsoft Word & Excel required.
• Knowledge of cGMPs required.

Preferred

• Sologic Certificate
• Direct or supporting aseptic manufacturing experience in bio/pharma industry desired.

Working Environment

• Vision Requirements: 14/14 Corrected Near-Point
• Pass Color Deficiency Test
• Ability to lift 30 pounds unassisted.
• Prolonged sitting required.

Location: Spokane, WA – On Site, Full- -Time Shift: Weekday Days, 8 hour shifts Compensation & Benefits That Start on Day One – Because Your Well Being Matters Hiring Wage: $81,800.00-$130,900, with opportunities for growth, promotion, and annual raises.

At Jubilant HollisterStier, we don’t believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success.

Starting On Your First Day, You Receive

• Medical, Dental & Vision coverage
• Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
• Life & AD&D Insurance
• Short-Term & Long-Term Disability Insurance
• Employee Assistance Program

Unlock Your Potential

Jubilant HollisterStier is an EEO/AA Employer . All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.