Senior Quality Assurance Specialist

1w1 week ago

Kindeva Drug Delivery

Brentwood, US · Full-time · $110,000 – $145,000

About this role

The Senior QA Specialist provides strategic quality oversight and leads projects that enhance compliance and operational efficiency. This role manages investigations, change control, and product release. Drives continuous improvement initiatives while collaborating across functions for regulatory alignment.

Lead complex document reviews to ensure manufacturing and testing comply with batch records, SOPs, and cGMP standards. Provide QA oversight for shop floor support, line clearance, in-process checks, deviations, and batch documentation. Influence corrective actions for non-conformances to prevent recurrence.

Operate effectively in a team environment and collaborate cross-functionally on quality initiatives under short timelines. Participate in internal GMP audits and represent QA during customer and regulatory audits. Communicate issues promptly to management with accountability for quality outcomes.

Collect, analyze, and interpret data to identify trends and recommend quality system improvements. Lead training, mentoring, and process efforts to build QA capability. Demonstrate advanced proficiency in aseptic techniques and deep knowledge of manufacturing operations.

Requirements

Bachelor's degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or other science-related discipline or minimum of 5 years experience in Pharmaceutical industry
Experience in Batch Record Review/Audit/Disposition
Combination of relevant education, aseptic training, and manufacturing/quality experience
Knowledge of cGMPs (USFDA, Health Canada, PIC/S and/or Eudralex)
Demonstrated decision making ability related to Incident Investigation, Corrective and Preventive Actions
Demonstrated capability in project management
Ability to work in a team environment within own team and interdepartmental teams
Must work under short timelines

Responsibilities

Lead and approve complex document reviews to ensure compliance with batch records, SOPs, and cGMP standards
Provide strategic QA oversight for manufacturing and testing activities, including shop floor support, investigations, and change management
Independently identify, resolve, and influence corrective actions for non-conformances in manufacturing operations
Perform timely reviews and exercise judgment in determining batch acceptability and product disposition
Collaborate cross-functionally to lead quality initiatives while maintaining compliance under short timelines
Collect, analyze, and interpret departmental data to identify trends and recommend improvements
Lead training, mentoring, and process improvement efforts for Quality Assurance colleagues
Participate in internal GMP audits and represent QA as subject matter expert during regulatory audits