Associate/Senior/Lead, 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 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:

• Associates Degree in Biology, Chemistry or related field required. 5 to 10 years related experience required with an Associate's Degree.
• Bachelor's Degree in a science field desired. 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.
• Microsoft Word & Excel required.
• 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.
• Ability to take leadership or controlling role on conflict and influencing outcomes and end results desired.
• Sologic Certificate desired.
• Knowledge of cGMPs desired.

Shift:Day

Compensation:

• The salary range for this position is $67,725 - $93,500 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

Unlock your potential with Jubilant HollisterStier! If you're seeking a dynamic and rewarding career, we welcome your application today!

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:

Human.Resources@jubl.com