WuXi AppTec

Quality Assurance Associate - Temp

Job Locations US-CA-San Diego
Job ID
2021-8529

Overview

The Quality Assurance Associate will be responsible for controlled documents and records at the HD Biosciences San Diego facility. Controlled documents may include SOPs (Standard Operating Procedures), forms, policies, and training records. The incumbent will review and revise existing SOP’s annually, oversee employee training, and ensure the quality management program is running efficiently.

Responsibilities

  • Performs QA document control function, including document login, tracking, processing, approval, distributing, and archiving and has overall responsibility for document control processes.
  • Process all Document Control Requests (DCR’s), assign document numbers, route and track the document review, approval and distribution.
  • Review document drafts for grammar, spelling and formatting and making corrections as needed for making documents effective for use.
  • Send out documents for periodic review requests to department heads
  • Maintain electronic folders of drafts, edits and approved/effective documents.
  • Maintain hardcopies of documents and update QA binders with current versions
  • Establish employee training matrix for all new employees, ensuring all training is completed and the training records are maintained and filed.
  • Maintains in house training programs including training matrix, training files, and audits of training files.
  • Assist with planning of internal and external audits to ensure compliance with current practices.
  • Help implement and evaluate QA standards that comply with industry regulations.
  • Train, support and advise 
  •  Management System
  • Perform other work-related duties as assigned and required.

Qualifications

Experience / Education   

  •  High School Diploma/GED required, Bachelor’s Degree preferred preferably with a life sciences discipline
  • 1-3 years Quality Assurance experience. 

 

Knowledge / Skills / Abilities:

 

  • Must have an understanding of documentation control systems and experience writing SOP’s.
  • Expertise with MS Word, Excel, Office software.
  • Identify areas for improvement and make constructive suggestions for change
  • Experience with implementing and managing key Quality Management System processes
  • Excellent organizational skills and attention to detail.
  • Effective communication (both oral and written) required for interacting with all departments within the company as well as clients and outside agencies.
  • Must be able to think critically and independent problem solving capabilities
  • Must show ability to present solutions to issues using good judgment; must show ability to apply previous lessons to future project work
  • Must be able to build rapport and effectively communicate issues and potential resolutions to team and supervisor
  • Must be a team player and have the ability to multitask across several areas
  • Ability to work in a fast paced environment and adapt to changes quickly

 

Physical Requirements:          

 

  • Must be able to work in environment with variable noise levels
  • Ability sit long periods of time
  • Ability to crouch, bend, twist, and reach
  • Clarity of vision
  • Must be able to perform activities with repetitive motions
  • 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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