SENIOR QA SPECIALIST - VALIDATION

LGM Pharma, LLC•Irvine, CA

1d•$75,000 - $90,000

About The Position

This role focuses on ensuring that facility, manufacturing, packaging, and laboratory equipment meet the required cGMP standards. The specialist will be responsible for authoring and executing qualification protocols and reports, managing performance qualifications, calibration, and maintenance of equipment and utility systems. They will also assist in the sourcing and procurement of equipment by qualifying vendors and contributing to the development of URS/FRS/DDS. The position involves maintaining the Validation Master Plan, potentially presenting qualification studies to auditors, and contributing to the design and improvement of the qualification system. The specialist will provide technical expertise on qualification policies and procedures, supervise contract personnel and vendors, and author qualification reports. Additionally, they will develop and execute matrix type validations, investigate exceptions and non-conformances, and troubleshoot technical issues. Other responsibilities and special projects may be assigned.

Requirements

Bachelor’s degree in sciences or engineering
5+ years experience in a highly regulated pharmaceuticals industry or related field
Demonstrated experience with qualification commercial processing a packaging equipment.
Proven track record of managing projects from start to finish on time and on budget.
Strong working knowledge of cGMP and regulatory standards for validation.
Experience in writing and reviewing SOPs, GMPs, governmental regulations and/or protocols for accuracy, traceability and compliance.

Responsibilities

Assists in assuring facility, manufacturing, packaging, and Laboratory equipment are qualified to the required cGMP standards.
Authors/approves and executes qualification protocols and reports.
Schedules, plans, manages performance qualifications, calibration and maintenance of equipment and utility systems and laboratory Instruments in coordination with operations, Quality Control and maintenance.
Assists sourcing and procurement of facility equipment and Laboratory Instruments through completion of following tasks: Qualification of Vendors Selected, Input to the development of the URS/FRS/DDS.
Assists with the routine calibration and maintenance of the Validation Master Plan for the site.
May present qualification studies to Regulatory and Client Auditors as required.
Assists with the design, maintenance, and continual improvement of the qualification system in line with cGMP standards.
Provides technical expertise and guidance on qualification policies and procedures and the implementation of those within the Production and Quality functional areas.
Occasionally supervises specialized contract personnel and outside vendors in the performance of contract services.
Summarizes studies and authors qualification reports in compliance with the cGMP standards and in a timely manner.
Develops and executes matrix type validations where applicable for processes and equipment with adequate supporting rationales.
Initiates and investigates exception reports and non-conformances, associated with the qualification studies. Troubleshoots and resolves technical issues.
Other responsibilities and special projects will be assigned based on business and customer needs.