- 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
Quality Assurance Specialist - San Mateo, United States - Actalent
Description
Description:
• Receives product quality complaints (typically via phone or fax or email), from healthcare professionals and patients
• Documents all incoming complaints in to complaint management system timely and notifies other QA specialists for start of investigations
• Provides acknowledgement letters to the complainant upon receipt of complaint
• Notifies appropriate organizations for any product replacement requests from the complainants
• Conducts follow up calls to the reporters as required
• Communicates any Safety events to Drug safety
• Provides general support to the quality systems group including but not limited to database maintenance and report outputs
• Shipment of prepaid Fedex labels to the complainant for sample return
• Performs returned sample receipt, storage and assessment.
• May participate in cross functional complaint related teams
• May perform investigation of minor complaints
• May perform basic data analysis in support of complaint investigations, trend reports and APQRs
• Perform reconciliation of Drug Safety events and with Medical information
• Ensure compliance with applicable regulatory requirements with current Good Manufacturing Practices (cGMPs)
• Normally receives general instruction on routine work, detailed instructions on new assignments
• Performs decommissioning of serialized products
Additional Skills & Qualifications
● Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs) and/or Good
Laboratory Practices (GLPs).
● Demonstrates basic knowledge of pharmaceutical call center activities.
● Demonstrates good verbal, written, and interpersonal communication skills.
● Demonstrates working knowledge in Microsoft Office applications.
● 2+ years of relevant experience in a GMP environment related field and a BS.
● Prior experience in pharmaceutical industry is beneficial.
● Desirable:
● Able to pay attention to details, thorough documentation and multitask
● Able to work well as a member of a team or group (team player)
Experience Level:
Entry Level
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.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
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.
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