Quality Control Group Leader Job in Caldwell 07006, New Jersey US

COMPANY INFORMATION:

Our client is one of the world's leading suppliers of transdermal and oral systems for the international pharmaceutical industry.

We are currently looking for a QC Group Leader with strong experience in analytical method validations/ transfers, HPLC and GC.

RESPONSIBILITIES REQUIREMENTS:         

  1. Perform analytical method validations/ transfers. Coordinate workload in QC Analytical Transfer Group.
  2. Facilitate analytical method transfers and validations incl. but not limited to generation/ review of transfer documentation (protocols, reports, methods, etc.) and hands- on execution of analytical transfers/ validations including method development as needed.
  3. Ensure group workload is organized to provide efficient and timely analytical support for multiple projects.
  4. Ensure compliance with company SOP’s, specifications, cGMP guidelines.
  5. Provide and coordinate training, particularly to transition methods from analytical transfers group to routine QC.
  6. Revise existing SOP’s and CS’s as necessary. Prepare new method SOP’s.
  7. Strong instrumentation incl. troubleshooting knowledge.
  8. Participate in internal and external project meetings.

KNOWLEDGE AND EXPERIENCE:

  1. BS/MS in Chemistry
  2. Five years experience in FDA regulated QC procedures and systems.
  3. Strong knowledge of analytical chemistry, specifically analytical method development, validation and transfer following applicable ICH Guidelines.  Familiarity with physical testing methods (Adhesion, Peel, Shear, Tack).
  4. Interpersonal, organization, problem solving skills.
  5. Able to communicate effectively both orally and in writing.

 

DURATION:  

Permanent

 

SALARY:

$65,000 – $75,000

 

LOCATION:

Caldwell, NJ Area

John Aiello
Technical Recruiter
Synerfac Technical Staffing
2001 Route 46, Suite 504

Parsippany, NJ 07054
973-299-9920
973-299-9942 Fax
jaiello@synerfac.com

http://www.synerfac.com /"www.synerfac.com