Overview
Jubilant HollisterStier LLC, Spokane’s largest manufacturing company, offers a full range of pharmaceutical and biopharmaceutical manufacturing services, supporting life‑changing medicines worldwide. The company is nationally recognized for producing sterile injectable vials and lyophilized products, and its allergy business leads the market in allergenic extracts.
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.
- A career you can grow: Opportunities for growth, promotion, and annual raises, with compensation reserved for high performance.
- A culture of improvement: We value continuous improvement, innovation, and hands‑on contribution.
- A stable industry leader: Supported by Jubilant Pharma, we combine stability with forward‑looking innovation.
Job Description
The Manufacturing, Manufacturing Compliance & Operations role is responsible for ensuring robust GMP compliance across ABU manufacturing operations while actively supporting production teams to improve efficiency, effectiveness, and overall manufacturing performance.
- Manufacturing Support & Operational Partnership
- Act as a primary compliance and operations partner to manufacturing supervisors and managers.
- Provide floor‑level support and real‑time guidance during manufacturing operations.
- Proactively identify and resolve issues that impact throughput, right‑first‑time execution, and schedule adherence.
- Support batch execution by assisting with decision‑making, troubleshooting, and escalation.
- Ensure compliance expectations are met while enabling practical, efficient execution of manufacturing activities.
- Compliance Oversight & Execution
- Own and oversee deviations, CAPAs, change controls, training compliance, and documentation.
- Ensure all records and quality events are timely, accurate, and inspection‑ready.
- Perform and lead deviation investigations, including root cause analysis and effectiveness checks.
- Drive closure of quality records with a focus on sustainable, operation‑friendly solutions.
- Maintain proficiency in TrackWise systems for deviations, CAPA, and change control.
- Process Improvement & Manufacturing Efficiency
- Identify, lead, and support continuous improvement initiatives across manufacturing.
- Analyze trends in deviations, batch performance, and operational inefficiencies to implement proactive improvements.
- Partner with manufacturing, QA, MSAT, and support groups to simplify processes, eliminate waste, and improve cycle times.
- Drive improvements in right‑first‑time, deviation reduction, and batch release timelines.
- Translate compliance requirements into practical, streamlined manufacturing processes.
- Documentation & Training Leadership
- Oversee generation, review, and optimization of SOPs, batch records, and associated manufacturing documents.
- Ensure documentation supports both compliance and operational efficiency.
- Provide and coordinate cGMP, job task, and operational training for manufacturing personnel.
- Coach staff on best practices for documentation, execution, and compliance behaviors.
- Leadership & Team Development
- Provide leadership, coaching, and performance management for assigned personnel.
- Develop team capabilities beyond transactional compliance to include problem‑solving and operational awareness.
- Partner with management to establish performance expectations aligned with safety, quality, and productivity goals.
- Support hiring, onboarding, and development of manufacturing and support staff.
- Cross‑Functional Collaboration
- Work closely with Quality Assurance, Maintenance, Engineering, MSAT, and other support functions.
- Ensure issues are addressed with balanced consideration of compliance, risk, and operational impact.
- Drive alignment between departments to improve end‑to‑end manufacturing performance.
- Participate in cross‑functional forums to address systemic challenges and improvement opportunities.
- Performance Monitoring & Reporting
- Support development and reporting of manufacturing performance metrics (e.g., deviations, RFT, cycle time, CAPA effectiveness).
- Analyze data to identify trends and recommend actionable improvements.
- Contribute to production monitoring, cost awareness, and resource optimization efforts.
Qualifications
- Bachelor’s degree in Biology, Chemistry, Engineering, Manufacturing, or related field required.
- Alternative: Bachelor’s degree preferred or 5+ years industry/related experience in lieu of degree.
- Manufacturing leadership experience 3+ years required.
- Demonstrated experience in both GMP compliance systems (deviations, CAPA, change control) and direct manufacturing support or operations.
- LSS Certification desired.
- Pharma manufacturing or related supervisory/management experience desired.
- Microsoft Word and Excel required, PowerPoint desired.
- Strong knowledge of cGMP regulations (21 CFR Part 210/211) required.
- Proficiency in quality systems (TrackWise or equivalent) required.
- Data analysis and problem‑solving in a manufacturing environment required.
- Ability to translate compliance requirements into practical execution required.
- Ability to influence without authority across functions required.
- Strong decision‑making in real‑time operational settings required.
- Effective communication with both shop floor and leadership required.
- Continuous improvement mindset with bias toward action required.
- Other physical requirements: exposure to allergens, working in aseptic areas, prolonged sitting and standing.
- Interpretation of cGMP regulations.
- Minimum travel subject to company policy, management reviews results after the fact.
- Provides analysis, diagnosis, or production tasks which noticeably impact end results.
Location & Shift
Spokane, WA — Full‑time onsite.
Shift: Monday–Friday, 7:00 AM–4:00 PM.
Compensation & Benefits
Hiring Wage: $102,100.00 – $163,300.00. Opportunities for growth, promotion, and annual raises.
Benefits begin on day one:
- Medical, dental, and vision coverage
- Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
- Life & AD&D insurance
- Short‑term & long‑term disability insurance
- Employee Assistance Program
Equal Employment Opportunity
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.