Lead Associate - QA Compliance

Jubilant HollisterStier; Spokane (WA); On-site; USD 56,000 - 66,000; Full time

Benefits offered by this job

Day-one benefits

Career growth opportunities

On-site Spokane location

Job summary

Jubilant HollisterStier LLC in Spokane, WA seeks a Lead Associate - QA Compliance to manage deviations, CAPA and RCA for product quality and safety. The role oversees data entry, investigations, and QA systems alignment with regulatory expectations.

You will lead RCA activities, coordinate with management, provide training, and support audits. On-site, full-time, with a competitive wage and day-one benefits, fostering continuous improvement and growth.

Qualifications

• Associates Degree in Biology, Chemistry or related field required.
• 5 to 10 years related experience required with an Associate’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.

Responsibilities

• Review deviations, investigations and CAPAs to ensure accuracy, consistency and compliance with SOPs/Policies and related guidelines/regulations.
• Facilitate deviations investigation/resolution and assess product impact; complete final assessment/lot disposition for QA management and client review.
• Enter data into database to support RCA and CAPA activities.
• Provide oversight of RCA activities including meeting prep, information sharing, minutes, and follow-up actions.
• Interface with management to assure task completion by due dates.
• Support quality systems and procedures to assure compliance and product quality and safety.
• Assist with implementation of corrective actions from deviations, audits or inspections.
• Provide deviations and CAPA metrics for management review.
• Work with departments to understand production/testing processes for accurate investigation documentation.
• Provide investigation training to QA and other departments to ensure consistency.
• Speak to deviations during regulatory and client audits.
• Assist with review/approval of minor deviations in QMS.
• Assist with extension requests approvals when permitted by procedure.
• Assist with RCA chart review for QAC team members.
• Act as QA SME on Change Control records within QMS.
• Provide leadership and guidance to QAC team members.
• Report performance issues to QAC supervisor.

Skills

Quality Assurance

Investigations

Technical writing

QA operations

QC analysis

Regulatory experience

cGMP knowledge

Bio/pharma manufacturing

Leadership

SOP compliance

Education

Associate degree in biology/chemistry

Bachelor’s degree in science

Tools

QMS software

Regulatory databases

Documentation systems

Job description

Career Opportunities: Lead Associate - QA Compliance (1953)

Join a Leader in Pharmaceutical Manufacturing — And Build What’s Next

AsSpokane’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 onsolving 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 tobuild something meaningful with a team that values your drive, skills, and ideas — you belong here.

Job Description:

The QA Compliance Lead 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 processes to ensure capture of appropriate details and conclusions in the investigation or corrective action documents.
• Provide investigation training as needed to the Quality Unit and other departments to ensure that investigations are handled consistently throughout the company.
• Speak to deviations during regulatory and client audits.
• Assist with reviews and approval of minor deviations in the QMS system.
• Assist with extension requests approvals when permitted by procedure.
• Assist with RCA chart review for the QAC team members.
• Act as QA SME on Change Control records within the QMS.
• Provide leadership and guidance to QAC team members.
• Report performance issues to QAC supervisor as they arise.
• Act as the QA Compliance Supervisor when requested by the QA Manager. (In the absence of the supervisor)

Qualifications:

Required:

• Associates Degree in Biology, Chemistry or related field required.
• 5 to 10 years related experience required with an Associate’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.

Preferred:

• Bachelor’s Degree in a science field desired.
• Minimum of 3 years related experience required with a Bachelor’s Degree.
• Direct or supporting aseptic manufacturing experience in bio/pharma industry desired.
• Lead Experience.
• Supervisory Experience.
• Knowledge of cGMPs desired.
• Ability to lift 30 pounds unassisted.
• Prolonged sitting required.

Location: Spokane, WA — On Site, Full Time

Shift: Weekday Nights – Monday-Wednesday + E/O Thursday – 6pm-6am

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

Hiring Wage: $40.85 – $48.06 + 10% shift differential, 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.

If you require assistance applying for a position, contact:
JHS‑[e-mail]

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.