Supervisor II - QC Compliance

Jubilant HollisterStier LLC, Spokane's Largest Manufacturing Company, and well-established member of the business community, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. Jubilant HollisterStier is a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is a proud member of the Jubilant Pharma family.

Our Promise: Caring, Sharing, Growing

We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources.

Job Description: The Quality Control Compliance Supervisor oversees key compliance activities within the QC laboratory, including laboratory equipment qualification, maintenance, and performance monitoring, data integrity, sample chain-of-custody procedures, and the laboratory training and documentation program. This role supports daily operations by coordinating compliance tasks, ensuring accurate and complete documentation, and reviewing associated records and reports. The supervisor maintains required safety, cGMP, and job-specific training programs for laboratory staff, and leads or supports laboratory compliance investigations as needed. The position ensures all compliance workflows meet established Service Level Agreement (SLA) expectations.

Qualifications:

• Bachelors of Science in Chemistry, Biology or related hard science required.
• 5 years related laboratory or pharmaceutical experience required.
• 2 years supervisory or relevant leadership experience required.
• Pharmaceutical experience preferred.
• FDA Regulated Industry Experience preferred.
• Client and Regulatory Interactions
• Coordinate and schedule maintenance, calibration, and performance verification activities for QC laboratory instruments, collaborating with Metrology as appropriate.
• Oversee analytical instrument qualification activities from initial evaluation and procurement through final release for operational use.
• Assess laboratory instruments for compliance with applicable regulatory, compendial, and industry standards.
• Participate in laboratory compliance and data integrity risk assessments.
• Oversee the training, onboarding, and development of new analysts.
• Ensure all laboratory personnel maintain current training compliance on required procedures.
• Adhere to and promote all plant safety programs and applicable GMP regulations.
• Provide supervision and technical guidance to analysts in resolving laboratory or data integrity related issues.
• Manage the performance evaluation process for assigned direct reports.
• Conduct periodic laboratory self-inspections to ensure compliance with GxP requirements, housekeeping standards, and safety expectations.
• Evaluate and recommend laboratory equipment to support test method requirements, regulatory compliance, and operational efficiency.
• Lead or support investigations involving unexpected results, data integrity concerns, or general laboratory compliance issues.
• Review and approve various procedures, protocols, and reports that are predominantly associated with analytical instrumentation and data integrity.
• Participate in client audits and regulatory inspections, and implement corrective actions or improvements based on observations or recommendations.
• Propose and defend process and procedural improvements to enhance laboratory operations.
• Interpret current CFR and GMP regulations and develop procedures to ensure laboratory compliance with relevant requirements
• Microsoft Word required.
• Microsoft Excel required.
• Microsoft PowerPoint required.
• Manual Dexterity required.
• Knowledge, practical application, and understanding of the sciences are necessary to perform the functions of this position required.
• Must utilize scientific literature, and make effective written and oral reports that are clear, accurate, and logical required.
• Knowledge of chemistry, statistics, computer-assisted data processing, and good-manufacturing practices is desirable required.
• Must demonstrate initiative and a willingness to learn required.
• Must have good understanding and knowledge of cGMP required.
• Must be self-motivated with good communication and human relation skills, and must be able to effectively schedule, prioritize, and organize their time required.
• Must demonstrate the ability to work in a team setting supporting project teams as a Quality Unit representative required.
• Accountability - freedom to act independently - is subject to practices/well defined policy, management reviews results after the fact required.
• Accountability - influence on end results - provides analysis, diagnosis or production tasks which noticeably impact end results required.
• Work effectively with peers from other departments, on project teams, and with those who report directly to this position required.
• Develop and effectively present training programs as related to safety, cGMP and job training required.

Shift: Monday-Friday 8:00AM-5:00PM

Compensation & Benefits:

This is an on-site, full-time position located in Spokane, WA.

Hiring Wage: $89,300.00 - $119,000 annually depending on experience, with opportunity for growth, promotion and annual raises. Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibit outstanding performance over a period of time in the role

• 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 plan
• Employee Assistance Program

Unlock your potential with Jubilant HollisterStier! If you're seeking a dynamic and rewarding career, we welcome your application today!

https://jubilantcareer.jubl.com/

*Please click on the Spokane, Wa. Link*

Jubilant HollisterStier is an EEO/AA Employer.

All qualified applicants will receive consideration for employment 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, please contact our HR Department at:

JHS-TalentAcquisition@jubl.com