Jubilant HollisterStier CMO · 3 days ago
QA Auditor- Weekday Night Shift
Jubilant HollisterStier LLC is Spokane’s Largest Manufacturing Company, providing services to the pharmaceutical and biopharmaceutical industries. The QA Auditor is responsible for ensuring that all products produced meet labeling, dating, and packaging requirements, while conducting inspections and audits of manufacturing operations to maintain compliance with cGMP standards.
Responsibilities
Process final container samples; perform inspection/sampling according to SOP, Protocol or client request memo
Review and approve product records and entries for completeness and accuracy
Assure that labeling and packaging lines are clean and free of materials and components from previous lots. Perform visual inspection of product vials and packaging over extended periods of time (8-10 hours/day, with appropriate breaks)
Assure that through a system of auditing that cGMPs are followed in manufacturing and finished product packaging areas
Recognize potential problems and/or document problems encountered. Follow up with department supervisors to assure corrective actions are taken to resolve any deficiencies in product quality or manufacturing systems and procedures
Conduct annual retention sample inspections
Other tasks as assigned
Qualification
Required
High school diploma or equivalent required
Minimum 2 years related experience required (with no degree)
Minimum 1 year related experience required with an Associate's degree. No experience required with a Bachelor's degree
This position requires the basic understanding of pharmaceutical manufacturing, problem solving skills, and interpersonal relations
Limited/elementary vocational knowledge required
Microsoft Word experience required
Position requires cGMP and pharmaceutical manufacturing knowledge
The Auditor must have a thorough understanding of the QA and manufacturing systems as related to the testing and packaging operation and batch records
14/14 Corrected Near-Point required
Pass Color Deficiency Test required
Ability to lift 40 pounds unassisted
Exposure to allergens required
Prolonged standing required
Bending and reaching. Ability to stoop to access lower shelves for samples/inspection required
Preferred
Associates of Science degree desired
Bachelor's degree desired
Excel desired
Advanced/specialized knowledge desired
Benefits
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
Company
Jubilant HollisterStier CMO
Jubilant HollisterStier (JHS) CMO provides comprehensive sterile fill-finish and lyophilization services, ensuring the consistent delivery of high-quality products that meet the needs of global healthcare markets and patients worldwide.