QA Training Asst

  • location: Somerville, NJ
  • type: Contract
  • salary: $21.57 - $25.38 per hour
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job description

QA Training Asst

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

 
location: Somerville, New Jersey
job type: Contract
salary: $21.57 - 25.38 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Responsible for providing administrative and clerical support to the Site Training Team in processing training activities related to training documentation management within applicable regulatory requirements, internal policies, and industry practices.
  • Responsible for ensuring training documentation is efficiently and accurately prepared, processed and archived.
  • Assure data related to training is available and maintained in an audit ready state.
  • Identifies and escalates technical and/or business issues promptly; must be able to have the ability to solve routine issues independently.
  • Establishes and maintains a safe work environment for self and co-workers.
  • This role requires cross functional relationship building and partnering with all levels of the organization to apply best practices and identify process improvements to ensure overall training effectiveness and efficiency.
  • Communicates effectively with management, quality unit, peers and colleagues within and outside the department for all training related issues.
70%:

  • Prepare and process training materials and documentation.
  • Ensure hard copy and eLMS data is consistently accurate, current and archived correctly.
  • Support special projects or other assignments, as required.
20%:

  • Assist in periodic review of local site training administration procedures to ensure alignment with current site initiatives, regulatory body requirements (FDA, DEKRA, AATB) and Global company Corporate training procedures.
  • Use Lean and Six Sigma tools to review processes and apply the right technologies to improve the overall way in which we work.
  • Apply Information Technologies to processes and learning that result in an overall improvement in quality, effectiveness and efficiency.
  • Observe and improve human-computer interactions to ensure quality, efficiency, and minimize (if not eliminate) human error.
10%:

  • Support internal and external audits; follow up on outcomes from audits to ensure Training is complying.
 
qualifications:
  • BA or BS Degree, or equivalent experience - Required
  • 3 - 5 years of experience in Medical Device, Pharmaceutical, Human Tissue, or Biotech Industry.
  • 1 - 3 years of experience working with electronic Learning Management Systems.
  • Expertise in using Microsoft Office Applications including Word, Excel, PowerPoint, and Outlook.
  • Ability to work on cross functional teams and apply influencing skills in a matrix environment along with the ability to partner with and influence key internal and external stakeholders.
  • Ability to adhere to deadlines with high workloads.
  • Communicates effectively with management, quality unit, peers and colleagues within and outside the department for all training related issues.
  • Excellent oral and technical writing skills, with the ability to interface effectively and professionally.
  • Demonstrated organization skills.
  • Demonstrated ability to multi-task and work independently.
  • Demonstrated ability to apply Information Technologies to processes and learning that result in an overall improvement in quality, effectiveness and efficiency.
  • Experience with manual training records and conversion to automated systems.
  • Experience assessing current training records and documentation.
  • Experience in using Lean and Six Sigma tools for process improvement, preferred.
  • Experience working in a validated environment, which includes knowledge of information security, proper system testing and overall knowledge of software development life cycles, preferred.
  • Knowledge of training plan, curriculum, and aid design and development
 
skills: FDA, Quality Assurance, MS-WORD, MS-EXCEL, MS-Powerpoint
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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