Quality Control Technician

Summit, New Jersey


Employer: System One Holdings, LLC
Industry: 
Salary: Competitive
Job type: Part-Time

Job Title: Quality Control Technician

Location: Summit, NJ

Type: Contract

Responsibilities
  • Perform testing of in-process, final product, and stability samples.
  • Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
  • Anticipate and troubleshoot problems.
  • Recommend corrective actions and participate in the development of best practices.
  • Understanding of regulatory guidelines and can independently develop, write and execute methods, protocols, reports and other related documents.
  • Complete all work in a timely manner.
  • Work and communicate effectively within the team to ensure timelines are met.
  • Perform peer review of testing data.
  • Review all data in accordance with applicable procedures and cGMP requirements.
  • Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
  • Complete all review in accordance with required release timelines.
  • Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.
  • Train new analysts to general job duties.
  • Complete necessary training to become a qualified trainer.
  • Perform training effectively.
  • Document training per procedural and cGMP requirements.
  • Support document revision, project, CAPA, and investigation/deviation related tasks.
  • Perform assigned tasks within a CAPA, deviation, or project
  • Draft and review technical documents, such as SOPs and protocols/reports.
  • Communicate effectively with management regarding task completion, roadblocks, and needs.
  • Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles.
  • Performs other tasks as assigned.


Requirements

Education:
  • Bachelor's degree required, preferably in Science.
  • 2-4 years of relevant work experience, preferably in a regulated environment.
  • An equivalent combination of education and experience may substitute.


Experience:
  • Hands-on experience with various bioanalytical techniques including ELISA, qPCR and FACS.
  • Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
  • Technical writing skills.
  • Problem-solving ability/mentality, technically adept and logical.
  • Ability to represent the interests of the group on cross-functional teams.
  • Ability to set priorities of the group and manage timelines.
  • Ability to work with management locally and globally.
  • Ability to communicate effectively with peers, department management and cross-functional peers.


Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

Created: 2024-09-06
Reference: 325889
Country: United States
State: New Jersey
City: Summit


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