What are the responsibilities and job description for the Associate/Senior/Lead, QA Compliance 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 QA Compliance Associate / Senior / Lead Associate provides support to the company Deviations, Corrective and Preventive Action (CAPA) program through a complete assessment of Root Cause Analysis (RCA) of deviations and vendor complaints / issues. Assure product compliance and product safety. Ensure accurate and timely data entry and oversight of the company Quality Systems related to Deviations, CAPA and vendor complaint activities.
- Review and approve minor deviations, investigations and CAPAs to ensure accuracy, consistency and compliance with applicable SOPs / Policies, Specifications and related guidelines / regulations.
- Lead, facilitate, and conduct deviations, non-conformances investigations.
- Author / draft investigation reports with minimal guidance.
- Ensure timely completion of investigations with accuracy, consistency and compliance with applicable SOPs / Policies, Specifications and related guidelines / regulations.
- Interview Subject Matter Experts (SMEs) and involved employee(s) across multiple shifts to investigate reported problems and assess the quality impact.
- Conduct investigational meetings with required team member(s) and Verify Investigational findings against documented process per SOP.
- Coordinate immediate actions in conjunction with QA and department management upon identification of a non-conformance.
- Utilize problem solving techniques and appropriate tools to determine root cause and appropriate causal factors.
- Facilitate root cause analysis meetings with key stakeholders to identify solutions for quality improvements based on identified trends.
- Work with cross functional team member(s) to develop appropriate CAPA actions.
- Ensure investigations, corrections and CAPA are generated and approved in a timely manner.
- Act as liaison as it relates to specific investigations during client calls and audits.
- Support and / or coordinate data collection required for management reviews, KPI reports, client trend review meetings, and all other established regular quality reporting and review mechanisms.
- Communicate / Escalate to management any issues or delays identified during the investigation process.
- Provide investigation training as needed to the Quality Unit and other departments to ensure that investigations are handled consistently throughout the company.
- Speak to assigned deviations during regulatory and client audits.
- Assist with extension requests approvals when permitted by procedure.
- Act as QA SME on Change Control records within the QMS.
- Provide guidance to QAC team members.
- Report performance issues to QAC supervisor as they arise.
Qualification :
Shift : Day
Compensation :
Benefits :
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 : $67,725 - $93,500
