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Quality Assurance Analyst: Medical Device Batch Records Reviewer
Ref No.: 18-03216
Location: Raritan, New Jersey
Position Type:Contract
Shift:First
Job Category:Biotech/Pharmaceutical
Benefits:Dental Insurance, Medical Insurance
*1 year contract position, with opportunity for extension or hire based upon performance and business need*

The company: 
Our client is an in vitro diagnostics company that makes products and diagnostic equipment for blood testing. They serve two primary industries in the medical field: clinical laboratories, by producing platforms and assays that test for a variety of diseases, conditions, and substances; and immunohematology, by providing the means to ensure blood transfusion recipients receive appropriate and compatible blood.

Qualifications:

·         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.
 
Duties:
Reviews executed device history records (batch records, testing records, forms, temperature charts, autoclave charts) to:
o   Verify the accuracy of the record.
o   Ensure the records are executed as required.
o   Ensure the records are compliant to Specifications/Requirements, Quality System Regulations and GMPs.
o   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.

Pay Rate: $25.50 per hour
Drug and background screenings required

On-Board Services provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.