WuXi AppTec

Supervisor ILS

US-MN-St. Paul
Job ID
2017-3338

Overview

Provides support for ILS Management, working with Technicians, Study Directors and Quality Assurance to resolve complex issues in a timely manner. In a team environment, works to facilitate/incorporate effective practices for the completion of tasks as needed. Please note this is a "working supervisor" position that will require some days in the lab. 

Responsibilities

  • Participate/Lead client audits tours and investigate findings.
  • Participate in pre-study meetings and coordinate special supply orders per study design.
  • Reviews protocol and specifications for understanding and execution of orders.
  • Performs timely review equipment: Validations, Qualifications and Calibrations.
  • Maintains awareness of activities by routine direct observation of facility. Interact frequently interdepartmentally to provide quality perspective on routine operations and support system. Address conditions/practices with appropriate personnel, documents and reports findings to Management.
  • Writes and revises Standard Operating Procedures as necessary.
  • Participates in quality and process improvement initiatives.
  • Stays current with changes in regulatory bodies as well as guidance documents.
  • Provides direction to staff for following Good Documentation Practices.
  • Maintains statistical performance metrics.
  • Performs analysis and investigation of adverse quality trends.
  • Facilitates development and coordination of preventative and corrective action plans.
  • Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required. Normally receives minimal instructions on routine work and detailed instructions on new assignments.
  • Works under close supervision from supervisor or senior personnel.
  • Ability to work in a team environment and independently as required.
  • In addition, to handling all supervisory adminstrative tasks, this job may require the Supervisor to perform lab duties on occasion.
  • Maybe required to work minimal weekend days.
  • 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 Practices and Good Documentation Practices.
  • Other duties as assigned

Qualifications

Experience / Education   

  • Bachelors’ degree or equivalent experience
  • Preferred (Ex. AALAS certifications)

 

Knowledge / Skills / Abilities:

  • Knowledge of GLP and GMP requirements, Good Documentation Practices highly is highly desirable
  • Ability to accomplish the described duties through the use of appropriate computer equipment and software (Microsoft Word, Excel, and Access)
  • Ability to record data accurately and legibly
  • Ability to use judgement 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
  • Must read, write and understand English
  • Proficient in Microsoft (Excel, Word, Outlook)

 

Physical Requirements:          

  • Must be able to work in Lab setting with exposure to Animals/biohazards/ Chemicals.
  • Must not have animal allergies to applicable species in this facility
  • Must be able to wear appropriate PPE
  • Must be able to work in environment with variable noise levels
  • Ability to stand /Sit/walk for long periods of time
  • Ability to Lift 10 lbs
  • Ability to crouch, bend, twist, and reach
  • Clarity of Vision
  • Ability to identify and distinguish colors

 

 

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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