Overview
Quality Assurance Specialist Jobs in Irvine, CA at Kinetic Personnel Group, Inc
Title: Quality Assurance Specialist
Company: Kinetic Personnel Group, Inc
Location: Irvine, CA
Quality Assurance Specialist (Lot Disposition)
Overview
Join a dynamic team committed to the development and production of life-saving biopharmaceutical products. This clinical and commercial biologics CDMO is dedicated to delivering innovative manufacturing solutions that support clients and enhance patient care worldwide.
Position Summary
The Quality Assurance Specialist (Lot Disposition) plays a key role in supporting quality operations while ensuring compliance with cGMP requirements and internal quality standards. This position works independently to resolve routine and moderately complex quality-related issues while contributing to continuous improvement initiatives.
Primary Responsibilities
- Review Manufacturing Batch Records and related production documentation to ensure completeness and compliance.
- Assist with API batch and lot disposition activities.
- Evaluate testing documentation generated by Microbiology and Chemistry departments.
- Compile, organize, and perform QA review of Batch History Records.
- Draft and support investigations, deviations, and excursion reports.
- Work closely with internal departments on discrepancy assessments, corrective actions, and quality approvals.
- Participate as the Quality representative on cross-functional and multi-site projects.
- Provide Quality oversight and support for both internal operations and external customers.
- Review and approve controlled documents associated with manufacturing processes, equipment, facilities, and utilities.
- Coordinate with departments to ensure review activities are completed efficiently and according to SOP requirements.
- Generate and maintain departmental metrics and reports for management review.
- Identify process gaps or procedural issues and recommend practical improvements.
- Troubleshoot quality-related concerns and help drive timely resolution through effective collaboration.
- Apply technical knowledge and quality principles to solve moderately complex compliance or operational issues.
- Support departmental and company initiatives focused on continuous improvement.
- Balance multiple priorities and deadlines with minimal supervision.
- Maintain a continuous state of inspection readiness.
- Contribute to departmental objectives and individual performance goals.
- Collaborate with management to meet operational targets and project timelines.
- Serve as a technical subject matter expert (SME) for assigned Quality functions.
- Review and sign documentation in accordance with approved procedures and authorization guidelines.
- Perform additional Quality oversight responsibilities and other duties as assigned.
Required Qualifications
- Bachelor’s degree, preferably in a Life Sciences discipline.
- 2–4 years of experience within the biopharmaceutical or pharmaceutical industry.
- Familiarity with cGMP regulations and industry compliance standards.
- Ability to interpret and apply Quality requirements in a manufacturing environment.
- Strong analytical and problem-solving skills with the ability to make sound independent decisions.
