WuXi AppTec

Manager, Quality Assurance

US-MN-St. Paul
Job ID
2017-3251

Overview

The Manager manages the day-to-day aspects of the Quality Assurance Department.  The Manager prepares and develops changes in procedures to keep QA current with regard to the practice of all appropriate cGMP, GLP, CFR, PTC, ICH and relevant foreign regulatory guidelines for biopharmaceuticals.

Responsibilities

  • Maintains QA systems as required by GLP and GMP.
  • Responsible for reporting deviations, CAPA, calibrations, etc.
  • Responsible for QA team.
  • Conducts safety and manufacturing inspection.
  • Responsible for internal and external client and/or supplier audits and final report reviews.
  • Recommends the hiring, transfer, promotion, discharge and salary changes of the staff.
  • Conducts employee reviews and responds to employee issues.
  • Coaches and mentors the staff.
  • Develops and conducts training to ensure the staff is adequately trained and qualified.
  • Develops response to internal/external audit findings.
  • Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
  • Ability to work in a team environment and independently as required.
  • Contributes to the overall operations and to the achievement of departmental goals.
  • Perform job specific tasks in compliance with applicable Regulations, International. Standards, and WuXi AppTec Policies and Standard Operating Procedures.
  • Thorough understanding of Good Laboratory Practices and Good Manufacturing Practice.
  • Other duties as assigned.

Qualifications

Experience / Education

  • Minimum 5 years of experience
  • Bachelor’s Degree or equivalent
  • GLP and GMP experience
  • Must have 3 or more years of experience managing personnel
  • Auditing experience

 

Knowledge / Skills / Abilities:

  • Ability to use judgment, clear problem-solving and decision-making skills
  • Ability to work under limited supervision and to handle complex problems
  • Excellent organizational and interpersonal skills.  Ability to communicate effectively with all levels of the organization
  • Thorough working knowledge of Regulatory Compliance, Quality System Management and Quality Assurance principles and practices
  • Proficient in Oral & Written communication skills
  • Need to be able to read, write and understand English
  • Proficient in Microsoft (Excel, Word, Outlook)

Physical Requirements:

  • Must be able to work in a Lab setting with exposure to animals/biohazards/chemical (list chemicals)
  • Must be able to wear appropriate PPE
  • Must be able to work in environment with minimal noise levels
  • Ability to stand for long periods of time
  • Clarity of vision
  • Ability to identify and distinguish colors
  • Must be able to perform activities with repetitive motions
  • Ability to lift 25 lbs routinely/often/occasionally
  • Ability to crouch, bend, twist and reach
  • Ability to push/pull X lbs routinely/often occasionally
  • Ability to work in variable temperatures high to freezing
  • Inside working conditions

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

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