Sr. Associate/Associate QA Compliance

About the role

Join a leader in pharmaceutical manufacturing as a QA Compliance Associate or Sr. QA Compliance Associate. You will support the company’s Deviations, Corrective and Preventive Action (CAPA) program through root cause analysis (RCA) of deviations and vendor complaints/issues. Ensure product compliance, safety, and accurate data entry into quality systems. Facilitate investigations, assess product impact, and complete final assessments for QA management and client review. Provide oversight of investigational RCA group activities, interface with management to ensure task completion, and support quality systems to maintain compliance and product quality.

Responsibilities

• Assess Root Cause Analysis (RCA) of deviations and vendor complaints/issues to ensure product compliance and safety.
• Ensure accurate and timely data entry and oversight of quality systems related to deviations, CAPA, and vendor complaints.
• Review deviations, investigations, and CAPAs for accuracy, consistency, and compliance with SOPs, policies, specifications, and regulations.
• Facilitate deviation investigations and resolutions, assess product impact, and complete final assessments for QA management and client approval.
• Provide oversight of investigational RCA group activities, including preparing meeting agendas, distributing information, publishing minutes, and following up on tasks.
• Interface with management and responsible individuals to ensure task completion by established due dates.
• Support quality systems, processes, and procedures (e.g., deviations, CAPA, vendor complaints) to ensure compliance and product quality.
• Assist QA and department management in implementing corrective actions stemming from deviations, audits, or regulatory inspections.
• Provide deviation and CAPA metrics for management review of system data.
• Collaborate with departments to understand production, analytical testing, and other processes to ensure accurate investigation details and conclusions.
• Lead, facilitate, and conduct deviation and non-conformance investigations (Sr. Associate).
• Author/draft investigation reports with minimal guidance (Sr. Associate).
• Interview Subject Matter Experts (SMEs) and involved employees across multiple shifts to investigate reported problems and assess quality impact (Sr. Associate).
• Conduct investigational meetings and verify findings against documented processes per SOP (Sr. Associate).
• Coordinate immediate actions with QA and department management upon identifying non-conformances (Sr. Associate).
• Utilize problem-solving techniques and tools to determine root cause and appropriate causal factors (Sr. Associate).
• Facilitate root cause analysis meetings with key stakeholders to identify solutions for quality improvements (Sr. Associate).
• Work with cross-functional teams to develop appropriate CAPA actions (Sr. Associate).
• Ensure investigations, corrections, and CAPAs are generated and approved in a timely manner (Sr. Associate).
• Act as a liaison during client calls and audits for specific investigations (Sr. Associate).
• Support and coordinate data collection for management reviews, KPI reports, client trend reviews, and other quality reporting mechanisms (Sr. Associate).
• Communicate/escalate issues or delays identified during the investigation process (Sr. Associate).
• Provide investigation training to the Quality Unit and other departments (Sr. Associate).
• Speak to assigned deviations during regulatory and client audits (Sr. Associate).
• Act as the QAC Lead Associate when requested by the QAC Supervisor (Sr. Associate).

Requirements

• Associate’s Degree in Biology, Chemistry, or a related field (required for both roles). Five years of experience may substitute for the degree.
• Bachelor’s Degree in a science field (desired for both roles).
• Sologic Certificate (desired for both roles).
• Minimum 2 years of experience (QA Associate) or 5 years of experience with an Associate’s Degree (Sr. QA Associate). A Bachelor’s degree may reduce the experience requirement to 2 years for the Sr. Associate role.
• Pharmaceutical and FDA-regulated industry experience (desired for QA Associate; required for Sr. QA Associate).
• Experience with technical writing, investigations, CAPA systems, building/manufacturing processes, and QC analysis (highly desired for QA Associate; required for Sr. QA Associate).
• Direct or supporting aseptic manufacturing experience in the bio/pharma industry (desired for both roles).
• Proficiency in Microsoft Word and Excel (required for both roles).
• Knowledge of cGMPs (desired for QA Associate; required for Sr. QA Associate).
• Effective verbal and written communication skills, with the ability to manage conflict and influence outcomes (required for Sr. QA Associate).
• Strong interpersonal skills and conflict management abilities (required for Sr. QA Associate).
• Ability to prioritize investigations based on impact to the facility and batch release (required for Sr. QA Associate).

Benefits

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

Pay

Hiring wage:

• QA Compliance Associate: $28.81 – $33.89 hourly, with opportunities for growth, promotion, and annual raises.
• Sr. QA Compliance Associate: $81,800 – $109,100 annually, with opportunities for growth, promotion, and annual raises.

Schedule

Monday–Friday, 8:00 AM–5:00 PM (on-site in Spokane, WA).