Associate & Sr. 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.

THIS JOB IS 100% ON-SITE IN SPOKANE, WA! RELOCATION ASSISTANCE AVAILABLE

Job Description:

The QA Compliance Associate & Sr. Associate provides support to the company Deviation, 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 Deviation, CAPA and vendor complaint activities.

Responsibilities:

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 Deviation 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. Deviation, 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 Deviation 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. Act as the QAC Lead Associate when requested by the QAC SUPERVISOR (in the absence of the QAC Lead
12. Speak to assigned deviations during regulatory and client audits.

Qualifications:

Sr. Associate Level:

• AS in Biology, Chemistry, or related field required; BS in a science field desired
• Sologic certification desired
• 5+ years of related experience with AS degree; 2+ years of related experience with BS 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 required
• Direct or supporting aseptic manufacturing experience in bio/pharma industry desired

Associate Level:

• AS in biology, chemistry, or related field required; BS in a science field desired
  • 5+ years of exp may be used in lieu of an AS degree
• Sologic certificate desired
• 2+ years of related experience required for AS; 0-2 years of experience for BS
• Pharmaceutical and FDA regulated industry experience desired
• Experience with technical writing, investigations, CAPA systems, building & manufacturing processes/systems, and QC analysis desired
• Direct or supporting aseptic manufacturing experience in bio/pharma industry desired

Shift: Monday - Friday; 8hr days

Compensation & Benefits:

This is an on-site, full-time position located in Spokane, WA.

• Hiring Wage: Sr. Associate: $77,969 - $93,600 annually with opportunity for growth, promotion and annual raises. See full list of benefits below for our complete compensation package. This is an exempt salaried position.
• Hiring Wage: Associate: $58,047.50 - $78,494.46 annually with opportunity for growth, promotion and annual raises. See full list of benefits below for our complete compensation package. This is a non-exempt salaried position.

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

https://jubilantcareer.jubl.com/

*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 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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