Quality Assurance Investigations Specialist

2 weeks ago

Marietta, Georgia, United States WuXi AppTec Full time
Overview

WuXi AppTec stands as a premier global provider of pharmaceutical and medical device capabilities, offering an extensive technology platform with worldwide operations. We are currently seeking a dedicated Quality Assurance Investigations Specialist to join our Laboratory Investigations Department.

This role entails conducting Out of Specification (OOS) Client Investigations and supporting the prompt completion of Corrective Action and Preventive Action (CAPA) Investigations, along with associated sub-systems.


Key Responsibilities

Essential Job Functions:
  • Execute OOS Investigations as directed by clients and Quality Assurance.
  • Engage with clients regarding the investigation process as needed.
  • Collaborate with various departments to contribute to Quality, PAR, CAPA, and ACAR investigations.
  • Monitor Laboratory Investigation Reports (LIRs), New Chemical Entities (NCEs), address client grievances, and assist in their resolution.
  • Oversee the implementation and training resulting from CAPA, and provide support in training initiatives.
  • Communicate with clients concerning both technical and non-technical inquiries related to investigation progress.
  • Gain hands-on experience by training across multiple laboratories to acquire a comprehensive understanding of testing protocols.
  • Participate in special projects as required.
  • Handle routine assignments following established procedures, demonstrating the ability to identify deviations from accepted practices.
  • Generally operate with minimal guidance on standard tasks and receive detailed instructions for new assignments.
  • Work under close supervision from senior personnel.
  • Exhibit the ability to function effectively both independently and as part of a team.
  • Be prepared to work during holidays and weekends as necessary.
  • May be required to work overtime.
  • Contribute to the overall efficiency and success of departmental objectives.
  • Perform job-specific duties in compliance with relevant regulations, international standards, and WuXi AppTec policies and standard operating procedures.
  • May assist in other departments as needed.
  • Undertake additional responsibilities as assigned.

Qualifications

Experience / Education:
  • Associate or Bachelor's degree in a scientific discipline.
  • A minimum of 2 years of relevant experience or 4 years without a degree.
  • Scientific technical knowledge and/or Quality Assurance experience in a regulated environment.
  • Preferred experience with the CAPA process.

Knowledge / Skills / Abilities:
  • Comprehensive understanding of Good Laboratory Practices and Good Manufacturing Practices.
  • Exceptional organizational skills and meticulous attention to detail.
  • Capability to work autonomously and collaboratively within teams.
  • Proficient in data analysis and interpretation.
  • Strong written communication skills.
  • Effective oral and written communication abilities.
  • Fluency in reading, writing, and understanding English.
  • Proficient in Microsoft Office Suite (Excel, Word, Outlook).

Physical Requirements:
  • Ability to work in an office environment with minimal noise.
  • Capability to operate in a laboratory setting with exposure to biohazards and chemicals.
  • Must wear appropriate personal protective equipment (PPE).
  • Ability to adapt to environments with varying noise levels.
  • Capacity to stand, sit, or walk for extended periods.
  • Ability to identify and differentiate colors.

Equal Opportunity Employer

WuXi AppTec is an Equal Opportunity Employer. We encourage applications from individuals of all backgrounds and experiences.

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