Quality Assurance Specialist I (Biotech)

Employment Type

: Full-Time


: Miscellaneous

Aerotek is seeking a Quality Specialist 1 for a premier biotech client located in Foster City, CA. We are seeking candidates with strong written and verbal communication skills and an interest in a career in the sciences.

  • Receives product complaints for pharmaceutical 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.
  • Requirements

  • Has a Bachelor's in Science degree.
  • Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
  • Demonstrates basic knowledge of FDA standards and quality systems.
  • Demonstrates good verbal, written, and interpersonal communication skills.
  • Demonstrates working knowledge in Microsoft Office applications.
  • Prior experience in pharmaceutical industry is plus
  • About Aerotek:

    We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

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