Sr. Associate, QA Compliance

About the role

Join a leader in pharmaceutical manufacturing and contribute to life-changing medicines worldwide. As Spokane's largest manufacturing company, Jubilant HollisterStier LLC provides a complete range of manufacturing services, specializing in sterile injectable vials, lyophilized products, and allergenic extracts for allergy and asthma treatments. This role offers the opportunity to solve complex problems, improve systems, and make a global impact.

Responsibilities

• Support the company’s Deviation, Corrective and Preventive Action (CAPA) program through comprehensive Root Cause Analysis (RCA) of deviations and vendor complaints/issues.
• Ensure product compliance and safety through accurate and timely data entry and oversight of Quality Systems related to deviations, CAPA, and vendor complaints.
• Lead, facilitate, and conduct investigations into deviations and non-conformances, authoring/drafting investigation reports with minimal guidance.
• Ensure timely completion of investigations with accuracy, consistency, and compliance with applicable SOPs, policies, specifications, and regulations.
• Interview Subject Matter Experts (SMEs) and involved employees across multiple shifts to investigate reported problems and assess quality impact.
• Conduct investigational meetings with required team members and verify findings against documented processes per SOP.
• Coordinate immediate actions with QA and department management upon identification of non-conformances.
• Utilize problem-solving techniques and 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 trends.
• Work with cross-functional teams to develop appropriate CAPA actions and ensure timely generation and approval.
• Act as a liaison during client calls and audits for specific investigations.
• Support and coordinate data collection for management reviews, KPI reports, client trend reviews, and other quality reporting mechanisms.
• Communicate/escalate to management any issues or delays identified during the investigation process.
• Provide investigation training to the Quality Unit and other departments to ensure consistent handling of investigations.
• 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 a related field (required). Bachelor’s degree in a science field (desired).
• Minimum of 5 years of related experience with an Associate’s degree or 2 years with a Bachelor’s degree.
• Pharmaceutical and FDA-regulated experience (required).
• Experience with technical writing, investigations, CAPA systems, building and manufacturing processes/systems, QA operations, and QC analysis.
• Proficiency in Microsoft Word and Excel.
• Knowledge of cGMPs (required).

Preferred Qualifications

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

Working Environment

• Vision requirements: 14/14 corrected near-point.
• Must pass a 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–$130,900.00, with opportunities for growth, promotion, and annual raises.

Benefits

Benefits start on day one and include:

• Medical, dental, and vision coverage.
• Flexible Spending Accounts (FSA) and Health Savings Accounts (HSA).
• Life and AD&D insurance.
• Short-term and long-term disability insurance.
• Employee Assistance Program.