Quality Assurance Specialist

Job Title: Quality Assurance Specialist II / III (Product Quality Complaints)

Job Description

We are seeking a dedicated Quality Assurance Specialist II / III to join our team. In this role, you will manage and lead various quality assurance tasks, including handling product complaints and ensuring compliance with global regulatory standards. This position requires a strong understanding of pharmaceutical product complaints, including OSD, small molecules, and parenterals. Your expertise will contribute to maintaining product quality and regulatory compliance across all sites.

Responsibilities

• Lead and perform clinical and commercial product complaint investigations in accordance with global regulatory and quality system requirements.
• Own complaint tracking, trending, and data analysis; prepare and publish quarterly commercial trend reports.
• Lead and coordinate complex complaint investigations, including root cause analysis and CAPA implementation.
• Manage special projects to improve complaint handling and quality systems.
• Serve as a subject matter expert for complaint management processes.
• Interface with regulatory agencies during inspections and audits.
• Author, review, and implement updates to controlled documents to ensure compliance.
• Support Annual Product Quality Reviews and complaint trend analysis reporting.
• Ensure timely escalation of critical and major complaints to management.
• Collaborate cross-functionally with internal and external stakeholders.
• Develop and maintain relationships with manufacturing sites, CMOs, and key partners.
• Support the development and execution of strategic Quality Assurance programs.
• Perform quality activities to ensure compliance with regulatory requirements and cGMPs.
• Analyze quality issues, identify deviations, and recommend solutions.
• Provide technical guidance, mentoring, and oversight to junior staff.

Essential Skills

• Proficiency in cGMPs, Quality System principles, and industry standards.
• In-depth knowledge of FDA, EMA, and global regulatory requirements.
• Strong verbal, written, and interpersonal communication skills.
• Proficiency in Microsoft Office applications and quality systems tools.
• Skills in manufacturing investigations, deviations, and CAPAs.
• Ability to work independently in a high-paced environment with tight timelines.

Additional Skills & Qualifications

• 5-8 years of relevant experience and a bachelor's degree in science or related fields; or 6 years of relevant experience and an advanced science degree.
• Deep knowledge and experience in quality assurance in a regulated manufacturing environment.
• Biopharmaceutical or Pharmaceutical experience is preferred.

Work Environment

The position offers flexibility with remote work on Mondays and Fridays as needed, while onsite presence is required on Wednesdays and Thursdays. The work environment fosters collaboration and requires the ability to manage timelines effectively. A strong emphasis is placed on maintaining compliance with global regulatory standard

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 23, 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