Sr. Associate, QA Compliance

Join a leader in pharmaceutical manufacturing and help build what’s next. As Spokane’s largest manufacturing company, Jubilant HollisterStier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support life-changing medicines around the world. We are nationally recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma. Jubilant HollisterStier is proudly part of the global Jubilant Pharma family.

About the role

The QA Compliance 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.

• 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.
• Act as the QAC Lead Associate when requested by the QAC Supervisor (in the absence of the QAC Lead Associate).

Requirements

• Associate’s degree in biology, Chemistry, or related field required. Bachelor’s degree in a science field desired.
• Minimum of 5 years related experience required with an Associate’s Degree. Minimum of 2 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.
• Microsoft Word & Excel required.
• Knowledge of cGMPs required.

Preferred Qualifications

• Sologic Certificate Direct or supporting aseptic manufacturing experience in bio/pharma industry desired.

Working Environment

• Vision Requirements: 14/14 Corrected Near-Point Pass Color Deficiency Test
• Ability to lift 30 pounds unassisted.
• Prolonged sitting required.

Schedule

Weekday Days, 8-hour shifts (on-site in Spokane, WA).

Pay

Hiring wage: $81,800.00 - $130,900, with opportunities for growth, promotion, and annual raises.

Benefits

Benefits start on day one and include:

• Medical, Dental & Vision coverage
• Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
• Life & AD&D Insurance
• Short-Term & Long-Term Disability Insurance
• Employee Assistance Program