QC Compliance Analyst

Regular
16 Elkins, East Brunswick
Posted 2 years ago

POSITION:   QC Compliance Analyst

LOCATION: 16 Elkins Road, East Brunswick, New Jersey 08816      

ENTITY: Avet Pharma Labs Inc. 

DUTIES:

  • Lead and assist work activities of the pharmaceutical laboratory unit/group/area/department and collaborates with Laboratory Head to create and monitor a system to accomplish FDA compliance within the quality control laboratory operations, which includes continuous updates in training system, instrument management system, reference standard system, regulatory updates with respect to QC Compliance system etc.
  • Provide technical project leadership, participating in protocol development and execution for test method development, validation/verification and related activities. Provide expert level troubleshooting of laboratory equipment, methods and processes.
  • Conduct training for new employees on data integrity, operation of new software, instruments and good documentation practice to harmonize with the system. Performs Operational and Performance Qualification for LabSolutions software of UV-visible spectrophotometer and RF-6000 Spectro fluorophotometer.
  • Oversee and assess quality control of testing of residual solvents, limit tests and related compounds in raw materials for release by using Gas Chromatography. Oversees Method Validation of Active Pharmaceuticals Ingredients for particle size by Malvern Mastersizer Scirocco 2000.
  • Report results draw conclusions and make data-based recommendations to management. Identifies product concepts and technical approaches, demonstrate concept and technical feasibility, formulate detailed development plans and execute such plans to meet objectives and commitments
  • Provide support in creation of Microsoft-based excel calculation templates according to CFR Part 11 and Waters EMPOWER 3 software auto calculation verifications.
  • Perform Analytical Method Development, validation and release testing using Malvern, Refractometer, Air Jet Sieve and Gas Chromatography.
  • Prepare new documents as per current USP, FDA, ICH guidelines for pharmaceutical drug substance and products, such as creation and revision of specifications, qualification plans/reports, validation/verification protocols/reports, and method transfer protocol/reports.
  • Revise and update standard operating procedures and test methods as needed. Review of Compendia (USP, EP, and BP) and perform assessment on changes to be implemented on timely basis.
  • Develops or implements policies, standards, or procedures to ensure regulatory compliance or to improve operations. Maintains Quality Control instrument inventory control by using Trackpro software.

EDUCATION: 

Master’s in Pharmaceutical Chemistry or Chemistry + 2 years of exp. in job as QC Compliance Analyst, Chemist, or similar.

FOR APPLYING TO THIS JOB:

mail your application to-

HR-CA1,

Heritage Pharmaceuticals/Avet Pharmaceuticals,

16 Elkins Road, East Brunswick, NJ 08816

or email your job application to-

 careers@avetpharma.com.

Job Features

Job CategoryQuality Control

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