Quality Assurance Specialist- Small Sponsor!

Job Title: Quality Assurance Specialist (GxP Audits)

Fully Onsite x 5 days a Week:

Job Description

The Compliance QA Specialist plays a vital role in supporting GxP inspection and audit activities within the inspection readiness program. They are responsible for audit preparation, closure, observation tracking, and records management. As part of continuous improvement initiatives, the specialist will assist in the administration and development of standardized templates for inspection readiness and ensure data accuracy within the eQMS application.

Responsibilities

• Maintain audit-related records throughout the program lifecycle.
• Obtain and compile data relevant to risk assessments.
• Assist with inspection readiness activities across multiple projects in various stages of development or commercialization.
• Develop standardized templates based on regulatory requirements and procedures.
• Conduct follow-up activities with internal stakeholders related to the inspection readiness program.
• Input and maintain inspection-ready information in the eQMS and SharePoint.
• Support internal and external stakeholders in monitoring supplier performance.
• Track and trend quality metrics related to supplier qualification, audits, and inspection programs.

Essential Skills

• Excellent attention to detail.
• Strong problem-solving and organizational skills.
• Knowledge of GxP processes related to vendor, partner, and supplier management.
• Familiarity with FDA Quality System Regulations and Pharmaceutical guidelines, 21 CFR Part 210 & 211, US and EU regulations, ICH guidelines, and industry standards.
• Proven organizational skills to obtain and present data across multi-functional groups.
• Strong written and oral communication skills.
• Ability to influence decision-makers and recommend effective solutions.
• Proficient in Microsoft Office applications.

Additional Skills & Qualifications

• BS/B.Sc preferably in life sciences or STEM disciplines.
• Minimum of 3 years experience in biotech, pharmaceutical, or related industry.
• Administrative experience in organizing and maintaining supplier and audit records.
• Ability to work with ambiguity and complexity.

Work Environment

The position is primarily office-based, requiring essential physical activities such as sitting, standing, and typing. The role involves light physical effort, such as lifting up to 20 pounds. The work schedule is onsite, Monday to Friday, from 8 AM to 5 PM.

This is a Contract position based out of Alameda, CA.

The pay range for this position is $50.00 - $70.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 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)

This is a fully onsite position in Alameda,CA.

This position is anticipated to close on Feb 11, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $50 - $70