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Quality Assurance Specialist I

2 months ago

Philadelphia, Pennsylvania, United States WuXi AppTec Full time
Job Description

Job Title: Quality Assurance Specialist I

Job Summary:

We are seeking a highly skilled Quality Assurance Specialist I to join our team at WuXi AppTec. As a Quality Assurance Specialist I, you will be responsible for ensuring the quality of our products and services by implementing and maintaining quality control processes.

Key Responsibilities:

  • Monitor and review laboratory testing data and records to ensure compliance with current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP)
  • Identify and address any deviations or non-conformities in laboratory testing data and records
  • Collaborate with laboratory and operations staff to provide quality perspective on routine operations and support systems
  • Compile and review raw data, batch records, and test results to ensure accuracy and completeness
  • Review and approve Non-conforming Events (NCE), Deviations, and Laboratory Investigation Reports (LIR)
  • Write and revise Standard Operating Procedures (SOPs) as necessary
  • Review and approve document change requests
  • Perform timely review of complex study files, such as Assay Validations, Qualifications, and Viral Clearance
  • Perform QA inspections, including GLP studies
  • Participate in quality and process improvement initiatives and project teams
  • Coordinate area training
  • Participate in internal audits as needed

Requirements:

  • 4+ years of relevant experience or equivalent
  • Bachelor's degree in a Science-related field or equivalent experience
  • Knowledge of GLP and cGMP requirements, PTC guidelines, and ISO17205 is highly desirable
  • Ability to accurately and reproducibly perform arithmetic, algebraic, and geometric calculations
  • Ability to record data accurately and legibly
  • Ability to use judgment as dictated by the complexity of the situation
  • Ability to understand and follow verbal or demonstrated instructions
  • Ability to work effectively as part of a team and to exhibit effective interpersonal skills
  • Ability to receive, comprehend, and to effectively communicate detailed information through verbal and written communication
  • Proficient in Oral & Written communication skills
  • Need to be able to read, write, and understand English

Our Values:

We value integrity, dedication, working together, and sharing success. We believe in doing the right thing and doing it right.

About WuXi AppTec:

We are a global contract research organization (CRO) that provides a comprehensive range of services to support the discovery, development, and manufacturing of pharmaceuticals and biologics. We are committed to providing opportunities for internal growth and development, and we value our employees as our greatest asset.