QA Specialist

Actalent • Foster City, CA

412d • $93,600 - $99,840 • Remote

About The Position

The Quality Assurance Specialist is responsible for managing change controls related to manufacturing products, processes, equipment, facilities, and computerized systems within a GMP environment. This role plays a crucial part in overseeing strategic, tactical, and operational goals, ensuring compliance with quality management system (QMS) expectations, and maintaining high-quality standards in the pharma/biotech industry.

Requirements

• 3-5 years of relevant experience in a GMP environment for pharma/biotech manufacturing
• BS or BA degree
• Experience with change control
• Quality assurance experience
• Document control experience
• Change control in a GxP environment - minimum of three years
• Technical writing skills
• Pharma/biotech industry experience - minimum of three years
• Project management skills - ability to manage timelines and prioritize tasks

Responsibilities

• Manage change controls related to manufacturing products, processes, equipment, facilities, and computerized systems.
• Review, initiate, complete, and document critical, major, and minor change controls.
• Facilitate cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance with QMS expectations.
• Navigate through complex change review discussions, facilitating decisions regarding approach and follow-up actions, and documenting the decisions and evaluations.
• Support management and monitoring of change records for adherence to organizational or departmental metric targets and maintenance of associated tracking tools/databases.
• Support the management review process through development and generation of quality system metrics and trending, escalating issues as required.
• Maintain and improve quality systems processes as needed.
• Work directly with operating entities and internal clients to ensure follow-up of change tasks.
• Participate in compliance audits as required.
• Maintain programs and processes to ensure high-quality products and compliance with current Good Manufacturing Practices (cGMPs).
• Write and/or implement changes to controlled documents (e.g., SOPs, Specifications, Methods) as needed.
• Provide guidance and technical knowledge to more junior staff and monitor the performance of daily tasks.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital insurance
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Administrative and Support Services
• Education Level: Bachelor's degree
• Number of Employees: 10,001+ employees