Quality Assurance Specialist II / III

Description

• Lead and perform clinical and commercial product complaint investigations in accordance with applicable global regulatory and quality system requirements.

• Own complaint tracking, trending, and data analysis across all company sites; prepare and publish quarterly commercial trend report.

• Lead and coordinate complex complaint investigations, including root cause analysis and the development, implementation, and effectiveness verification of corrective and preventive actions (CAPAs).

• Manage and lead special projects aimed at improving efficiency, compliance, and effectiveness of complaint handling and quality systems.

• Serve as a subject matter expert for complaint management processes, including participation in beta testing and implementation of new systems and tools.

• Interface with regulatory agencies as required, representing company during inspections and audits; prepare and present complaint-related data and documentation to regulatory authorities.

• Author, review, and implement updates to controlled documents (e.g., SOPs, work instructions, protocols) to ensure ongoing compliance and continuous improvement.

• Support Annual Product Quality Reviews (APQRs), and complaint trend analysis reporting for commercial products.

• Ensure timely escalation of Critical and Major complaints and present relevant information to management.

• Collaborate cross-functionally and globally with internal and external stakeholders to ensure alignment and effectiveness of the complaint management process.

• Develop and maintain effective working relationships with manufacturing sites, CMOs, Drug Safety, Theracom, and other key partners.

• Support the development and execution of strategic Quality Assurance programs and initiatives.

• Perform a broad range of quality activities to ensure compliance with applicable global regulatory requirements and current Good Manufacturing Practices (cGMPs).

• Maintain and continuously improve programs and processes that ensure product quality and regulatory compliance.

• Analyze complex quality issues, identify deviations from accepted practices, assess potential impact, and recommend appropriate solutions.

• Provide technical guidance, mentoring, and oversight to junior staff; monitor performance of routine complaint-handling activities.

Additional Skills & Qualifications

Knowledge, Experience and Skills

• Demonstrate strong proficiency in cGMPs, Quality System principles, and applicable industry standards.

• In-depth knowledge of FDA, EMA, and global regulatory requirements and their interface with manufacturing, distribution, and maintenance functions.

• Exhibit strong verbal, written, and interpersonal communication skills, including technical writing for regulatory and quality documentation.

• Demonstrate proficiency in Microsoft Office applications and related quality systems tools.

• Strong experience in manufacturing investigations, deviations and associated CAPAs.

• Ability to work independently in a high-paced environment with tight timelines, while maintaining accuracy and quality.

• Possesses critical thinking skills when making sound quality decisions based on risk management and available data.

Basic Qualifications

• 5-8 years of relevant experience and a bachelor’s degree (preferred) in science or related fields; or 6 years of relevant experience and an advanced science degree or MS.

• Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment.

• Broad experience across areas such as CMO QA, validation, QRM, drug development or

• Biopharmaceutical or Pharmaceutical experience is preferred.

This is a Contract position based out of Foster City, CA.

The pay range for this position is $40.00 - $65.00/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 hybrid position in Foster City,CA.

This position is anticipated to close on Apr 3, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $40 - $65