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Scientist 2
Ref No.: 18-03821
Location: Raritan, New Jersey
Start Date / End Date: 06/11/2018 to 06/09/2019
Education
Degree Type Major/Certification Required Preferred
Bachelor's Degree active
Master's degree

Job Description & Requirements
Job Type: Recruited Resource - General Temp Number of Positions: 1
System Location: OCD - 6118 Created Date: 5/30/2018
Job Title: Scientist 2
CWR Type: W-2 Reason: Resignation/Open Position

Qualifications:
See attached job qualifications.

Responsibilities:
See attached job qualifications.

Comments/Special Instructions
Please see attached job description.
Work Location: 1001 US Highway 202 USRAR, Raritan, NJ 08869 United States
Start Date: 6/11/2018 Work Days:
Sun Mon Tue Wed Thu Fri Sat
active active active active active
End Date: 6/9/2019
Start Time: 8:00 AM Total Reg Hours: 40.00
End Time: 5:00 PM Overtime Required:
Lunch Time: 1 Hour


Attached Documentation:


JOB TITLE: QUALITY ANALYST

  • Bachelor's Degree in Medical Technology or equivalent scientific field is preferred and/or a minimum of 3 years professional experience in an FDA-regulated environment or equivalent industrial experience.
  • Understanding and application of scientific principles and methodologies with regard to medical technology, and life science.
  • Thorough knowledge of FDA, QSR, ISO and GMP requirements for pharmaceuticals and medical devices.
  • Additional skills required for this position include the following: the ability to schedule work load to meet department and team goals with minimum supervision, good organizational and time management skills to meet multiple and changing priorities, good written and verbal communication skills, the ability to interact with various department personnel.
  • Strict attention to detail and the ability to focus attention and work in a fast paced environment are key to success in this position.

Reviews executed device history records (batch records, testing records, forms, temperature charts, autoclave charts) to:
  • Verify the accuracy of the record.
  • Ensure the records are executed as required.
  • Ensure the records are compliant to Specifications/Requirements, Quality System Regulations and GMPs.
  • Ensure compliance with established processes and procedures.

  • Provides final approval of executed device history records.
  • Follows up with Operations or laboratory personnel to correct errors device history records.
  • Generates Nonconformance records in the electronic Nonconformance Management system when Nonconformance's are identified during a device history record review.
  • Prepares and verifies accuracy of Certificates of Analysis and Certificates of Manufacturing.
  • Uploads approved CoAs and Antigrams to applicable electronic systems.
  • Supports investigations for customer complaints by performing batch review of impacted area.
  • Files completed Device History records and Device History files.
  • Assists in the archiving of Device History Files and other quality records.