Lead Associate, QA Compliance

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 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. Essential duties include:

1. Review deviations, investigations and CAPAs to ensure accuracy, consistency and compliance with applicable SOPs/Policies, Specifications and related guidelines/regulations.
2. Accountable for facilitating deviations investigation/resolution, assessing product impact and for completing/writing final assessment/lot disposition for QA Management and Client review and approval.
3. Enters data into database in support of the corporate RCA and CAPA activities.
4. Provide oversight of investigational RCA group activities including preparation of meeting agenda, providing necessary information to meeting participants, publishing of meeting minutes, and follow-up on agreed upon activities and tasks.
5. Interface with management and responsible individuals to assure task completion on or before established due dates.
6. Responsible for supporting quality systems, processes and procedures (e.g. Deviations, CAPA, Vendor complaint, etc...) to assure compliance and product quality and safety.
7. Accountable for assisting the QA and applicable Department Management to ensure and follow up on implementation of corrective actions that stem from deviations, audit or regulatory inspections.
8. Provide deviations and CAPA metrics as needed in support of management review of system data.
9. Work extensively with appropriate department(s) to gain an understanding of the production/analytical testing process and other applicable process to ensure capture of appropriate details and conclusions in the investigation or corrective action documents.
10. Provide investigation training as needed to the Quality Unit and other departments to ensure that investigations are handled consistently throughout the company.
11. Speak to deviations during regulatory and client audits.
12. Assist with reviews and approval of minor deviations in the QMS system.
13. Assist with extension requests approvals when permitted by procedure.
14. Assist with RCA chart review for the QAC team members.
15. Act as QA SME on Change Control records within the QMS.
16. Provide leadership and guidance to QAC team members.
17. Report performance issues to QAC supervisor as they arise.
18. Act as the QA Compliance Supervisor when requested by the QA Manager. (In the absence of the supervisor)
    

Qualifications:

• Associates Degree in Biology, Chemistry or related field required. Bachelor's Degree in a science field desired.
• Sologic Certificate desired.
• 5 to 10 years related experience required with an Associate's Degree. Minimum of 3 years related experience required with a Bachelor's Degree.
• Pharmaceutical and FDA Regulated Experience required.
• Experience with technical writing, investigations, CAPA system, building and manufacturing processes/systems, QA operations systems, and QC analysis is required.
• Direct or supporting aseptic manufacturing experience in bio/pharma industry desired.
• Lead experience desired. Supervisory experience desired.
• Working knowledge of Microsoft Word & Excel required.
• Knowledge of cGMPs desired.
• Basic exchange of information, managing conflict and influence outcomes desired.
• Must have demonstrated effective verbal and written communication with all levels of staff.
• Must have demonstrated strong interpersonal skills and conflict management.
• Must have ability to prioritize investigations based on impact to the facility and release of batches.
• Provides analysis, diagnosis or production tasks, which noticeably influence results.
• Take leadership or controlling role on end results desired.
• Physical requirements: ability to lift 30 pounds unassisted, prolonged sitting required.
  

Shift: Day

Compensation:

• The salary range for this position is $65,479 - $79,750 depending on experience.
  

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
  

Optional Benefits:

• Voluntary Life and AD&D for employee & family
• Supplemental Medical coverage (Critical Illness, Hospital Indemnity and Accident coverages)
• Pet Insurance
• ID Theft Protection
• Perk Spot Discount Program

Jubilant HollisterStier is a great place to grow!
If you're up for a rewarding challenge, we invite you to take the first step and apply today!

https://www.jublhs.com/careers/career-opportunities
*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 their protected veteran status and will not be discriminated against on the basis of disability.

If you require assistance applying for a position, please contact our HR Department at: