Sr. Associate, QA Compliance

Jubilant Pharma, LLC; Spokane (WA); Presencial; USD 82.000 - 109.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Dental, Vision

FSA/HSA

Life & AD&D Insurance

Disability Insurance

Employee Assistance Program

Descripción de la vacante

Jubilant HollisterStier LLC in Spokane, WA is seeking a QA Compliance Associate to support the CAPA program through RCA of deviations and vendor issues. You will ensure product compliance, safety, and timely data entry within the quality systems.

The role involves leading investigations, drafting reports, and coordinating cross-functional actions to meet SOPs and regulatory standards. Qualifications include an Associate degree in biology or chemistry (or related field) with pharma/FDA

Formación

• Associates Degree in Biology, Chemistry or related field required.
• Bachelor’s Degree in a science field desired.
• Sologic Certificate is required.
• 5+ years related experience with an Associate’s Degree.
• 2+ years related experience with a Bachelor degree.
• Pharmaceutical and FDA regulated experience required.

Responsabilidades

• Lead, facilitate, and conduct deviations, non-conformances investigations.
• Author/draft investigation reports with minimal guidance.
• Ensure timely completion of investigations with accuracy and compliance with SOPs/Policies.
• Interview SMEs and involved employees across multiple shifts to investigate reported problems.
• Coordinate immediate actions with QA and management upon non-conformance.
• Utilize problem solving techniques to determine root cause.

Conocimientos

cGMP knowledge

Verbal and written communication

Conflict management

Prioritization

QA documentation tools

Aseptic manufacturing experience

Educación

Associate degree in Biology, Chemistry or related field

Bachelor’s degree in a science field

Herramientas

CAPA system

Quality Assurance SOPs

Descripción del empleo

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.
• Act as the QAC Lead Associate when requested by the QAC SUPERVISOR (in the absence of the QAC Lead Associate)

Qualifications:

• Associates Degree in Biology, Chemistry or related field required.
• Bachelor’s Degree in a science field desired.
• Sologic Certificate
• 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.
• Experience with technical writing, investigations, CAPA system, building and manufacturing processes/systems, QA operations systems, and QC analysis is required.
• Direct or supporting aseptic manufacturing experience in bio/pharma industry desired.
• Knowledge of cGMPs required.
• Basic exchange of information.
• Managing conflict and influencing outcomes.
• Must have demonstrated effective verbal and written communication with all levels of staff.
• Must have demonstrated strong interpersonal skills and conflict management.
• Must have ability to prioritize investigations based on impact to the facility and release of batches.
• Provides analysis, diagnosis or production tasks, which noticeably influence results.
• Take leadership or controlling role on end results desired.

Other Physical requirements:

• Ability to lift 30 pounds unassisted.
• Prolonged sitting required

Location: Spokane, WA — On Site, Full-Time

Compensation & Benefits That Start on Day One — Because Your Well Being Matters

Hiring Wage: $81,800 – $109,100 annually , 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:

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

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.

Our Promise: Caring, Sharing, Growing

We are committed to enhancing value for customers and stakeholders by delivering innovative and economically efficient solutions, always with care for the environment and society.