- 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
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Quality Assurance Specialist - San Mateo, United States - Actalent
Description
Description:
● Receives product complaints for products from the US and Canadian markets.
Documents in Quality System for investigation for product complaints and triages safety events to Pharmacovigilance Department. Performs or provides support for product complaint investigations
● Performs a variety of activities to ensure compliance with applicable regulatory requirements.
● Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs)
● Performs data analysis in support of complaint investigations and quarterly trend reports
● Provides support for internal and external audits
● May support in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products
● May assist lead/coordinator with investigations and corrective and preventive action (CAPA)
relating to manufactured products
● Assist with product-complaint escalations, field alert reports, and product recalls
● Assist with cross-functional improvement projects
● Manages product complaint samples from receipt through destruction
● Normally receives general instruction on routine work, detailed instructions on new assignments
Skills:
Attention to detail, Science degree
Additional Skills & Qualifications:
● Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs) and/or Good
Laboratory Practices (GLPs).
● Demonstrates basic knowledge of FDA / EMEA standards and quality systems.
● 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.
● 3+ years of relevant experience and an AA degree.
● Prior experience in pharmaceutical industry is beneficial.
● Desirable:
● Able to work in cross-functional project teams and CMOs, in different time zones
● Able to pay attention to details 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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