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Jubilant HollisterStier LLC

QA Ops Manager

Jubilant HollisterStier LLC, Spokane, Washington, United States, 99254

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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

QA Manager, supports Quality Assurance activities on weekday nights (B shift). Provide on-site QA oversight for drug product manufacturing, packaging, and labeling operations during weekday nights (B shift) operations. Perform real-time batch record review and approval to support timely product release. Lead or support investigations into deviations, non-conformances, and quality events occurring during weekday night operations. Ensure compliance with cGMP, internal procedures, and regulatory requirements. Serve as the QA decision-maker for B shift operations, escalating issues as appropriate. Collaborate with cross-functional teams including Manufacturing, Quality Control, and Engineering to resolve quality issues. Support

change control ,

CAPA , and

risk assessments

as needed. Participate in internal and external audits and inspections, providing documentation and responses as required. Maintain and promote a culture of quality and continuous improvement across weekday night operations. Provide training and mentorship to QA associates and other staff working weekday nights. Ensure the issuance of batch production records and printed packaging components as required by manufacturing processes. When required, establish objectives and conduct performance reviews with direct report personnel. Submit justifications for capital budget items as needed and ensure the approved items are ordered, received and implemented in a timely manner. Qualifications

Bachelor of Arts or Science required. 10 years of experience in lieu of a degree required. Minimum 5-10 years' experience required. Supervisory experience required. FDA regulated industry and Pharmaceutical experience desired. This position requires knowledge and interpretation of GMP's and quality systems. Ability to identify deficiencies and support identified solutions required. Shift

Weekday Nights, Monday-Wednesday E/O Thursday 6pm-6am Compensation & Benefits

This is an on-site, full-time position located in Spokane, WA. $102,100.00 - $163,300

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. Shift Differential: 10% for 12-hour night shift. 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! 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 .

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