What are the responsibilities and job description for the QA Validation Specialist/Senior Specialist position at Jubilant HollisterStier LLC?
Jubilant HollisterStier LLC, a well-established member of the business community in Spokane, Washington, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. 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 Specialist / Sr. Specialist, QA Validation will provide technical expertise via review and approval of documents including but not limited to Protocols, Acceptance Reports, SOPs and Specifications. The QA Validation Specialist will provide project and client support as a quality representative. Essential responsibilities include but are not limited to :
- Work with the production, engineering, maintenance, IT, and technical services departments to assure that all required prerequisite documentation is appropriately developed to support process, cleaning, facilities, aseptic, and filling / packaging activities.
- Track and provide technical direction for new and continued validation of processes and equipment to ensure compliance with internal policies and procedures, current industry standards, cGMPs and current regulatory requirements.
- Review product transfer protocols and reports, assess impact to product quality and determine appropriate actions.
- Create, and write required SOPs pertaining to documentation and QA Validation.
- Review and approve validation protocols, acceptance reports, SOPs and specifications.
- Recognize compliance issues that may occur and provide QA SME support for change control and system improvement.
Qualifications :
Shift : Day
Compensation & Benefits :
This is an on-site, full-time position located in Spokane, WA.
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
Optional Benefits :
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 :
Human.Resources@jubl.com
Salary : $78,968 - $113,900
