Job Details

Join to apply for the QA Compliance Associate-Weekdays role at Jubilant HollisterStier CMO

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 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.

Responsibilities

• Review Deviations, investigations and CAPAs to ensure accuracy, consistency and compliance with applicable SOPs/Policies, Specifications and related guidelines/regulations.
• 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.
• Enter 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. Deviations, 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 Deviations 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.

Qualifications

• Associates Degree in Biology, Chemistry or related field required.
• 5 years of experience may be used in lieu of an Associates degree.
• Bachelors Degree in a science field desired.
• Minimum 2 years of experience required. Bachelors degree can be used in lieu of experience.
• Pharmaceutical and FDA regulated industry experience desired.
  
• Experience with technical writing, investigations, CAPA systems, building & manufacturing processes/systems, and QC analysis is highly desired.
• Direct or supporting aseptic manufacturing experience in bio/pharma industry desired.
• Microsoft Word & Excel experience required.
• Knowledge of cGMPs desired.

Shift & Location

Shift: Weekday Days, Monday Friday. This is an on-site, full?time position located in Spokane, WA.

Compensation & Benefits

• Hiring Wage: $30.99 $41.93 hr. depending on experience, with opportunity for growth, promotion and annual raises.
• 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

EEO Statement

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.

Contact

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