WuXi AppTec

Associate Quality Assurance Specialist

Job Locations US-NJ-Plainsboro
Job ID
2021-8372

Overview

 

WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform with global operations. As an innovation-driven and customer-focused platform, WuXi AppTec Group provides a broad and integrated portfolio of services to help our worldwide customers and partners shorten the discovery and development time and lower the

cost of drug and medical device R&D through cost-effective and efficient solutions.

At our Laboratory Testing Division, we provide a world class, globally integrated testing solution for drug development and medical device innovation. We enable scientists to transform ideas into the best healthcare products, accelerate the race from bench to bedside, and ultimately improve human life.

Our New Jersey site specializes in small molecule bioanalytical, drug metabolism, and pharmacokinetic services to the pharmaceutical, animal health and agrochemical industries.  We are seeking an Associate Quality Assurance Specialist  within our Quality Assurance Group located in Plainsboro, NJ. 

Responsibilities

 

Job Summary: The Associate Quality Assurance (QA) Specialist will have the responsibility of monitoring regulated study-specific and facility-related data/records/files via inspections and audits. Additional responsibilities may also include participating in training activities and assisting with departmental administrative duties, as assigned.

 

Essential Job Functions:

  • Maintains a current awareness of EPA, FDA, and OECD Good Laboratory Practice (GLP) regulations and any other related Regulations which may apply to company activities.
  • Evaluates current laboratory practices. Recommends changes or modifications to laboratory procedures in order to facilitate compliance with GLP standards.
  • Conducts audits (protocol/plan, raw data, and final report audits for accuracy and completeness, verifying that the final reports accurately reflect the raw data generated) and in-lab critical phase inspections of any GLP-regulated study performed at the laboratory for conformance to the final protocol/plan, SOPs, and relevant GLP regulations.
  • Conducts inspections of laboratories/facilities
  • Conducts audits of employee training files.
  • Prepares written records of all inspections and audits. Submits findings to the study director, and/or principal investigator (or laboratory supervisor, when appropriate) and management, indicating deviations from or conformance with GLPs, protocol/plan, methods and SOPs.
  • Reports periodically to QA management regarding quality issues and status of inspection/audit activities.
  • Assists in reviewing, writing, and maintaining up-to-date SOPs and controlled documents for the QA unit.
  • Updates the master schedule as required by GLPs.
  • Promotes company’s safety policies, practices and procedures in order to maintain a safe work environment.
  • Other duties as assigned by QA management

Qualifications

 

Job Requirements:

Experience / Education   

  • Bachelor’s degree in biology, chemistry, or related field or equivalent work experience.
  • At least 2 years of Quality Assurance experience preferred
  • Familiarity with Good Laboratory Practice standards and experience working in a GLP regulated research environment
  • Any similar combination of education and experience

 

Knowledge / Skills / Abilities:

  • Knowledge of EPA, FDA, and OECD Good Laboratory Practice (GLP) regulations and commonly used concepts, practices, and procedures within GLP QA field
  • Must work well with numbers
  • Detail-oriented and highly organized
  • Effective oral and written communication skills
  • Excellent interpersonal skills
  • Computer skills: working knowledge of Internet, MS Word, Excel, Outlook, SharePoint and PowerPoint
  • Ability to multitask and work under pressure of multiple projects and deadlines
  • Ability to effectively prioritize workload and manage changes in direction
  • Must be able to record and keep essential records for a regulated environment

 

Physical Requirements:  

  • Must be able to work in an office environment
  • Must be able to work in laboratory setting with exposure to biohazards
  • Must be able to wear appropriate personal protective equipment (PPE)
  • Must be able to work in environments with variable noise levels
  • Must have the ability to stand /sit/walk for extended periods of time
  • Must have the ability to lift/push/pull 10 lbs occasionally
  • Must have the ability to identify and distinguish colors
  • Must have the ability to work in indoors/outdoors at variable temperatures

 

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

 

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  Employees holding this position will be required to perform any other job-related duties as requested by Management.

 

 

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