QA Compliance Associate/Sr. Associate Fri - Sun Nights

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 / Sr. 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 responsibilities include :

• Review Deviations, investigations and CAPAs to ensure accuracy, consistency and compliance with applicable SOPs / Policies, Specifications and related guidelines / regulations.
• 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.
• Enters data into database in support of the corporate RCA and CAPA activities.
• 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.
• Interface with management and responsible individuals to assure task completion on or before established due dates.
• Responsible for supporting quality systems, processes and procedures (e.g. Deviation, CAPA, Vendor complaint, etc...) to assure compliance and product quality and safety.
• 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.
• Provide Deviation and CAPA metrics as needed in support of management review of system data.
• 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.

Sr. Associate (In addition to above)

Qualifications : Associate :

Sr. Associate :

Both Associate and Sr. Associate :

Shift : Friday - Sunday Nights 5pm - 5 : 30am (3x12)

Compensation :

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

Associate : $30.01 - $35.30

Associate : $30.01 to $40.59 per hour

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 : $67,725 - $102,000