GMP SPECIALIST-ASEPTIC/FDA MANUFACTURING

Location: Edison, NJ
Date Posted: 04-29-2018
Include the following. Other duties may be assigned.
 
  • Leadership role in site compliance Operations meetings.
  • Conducts GMP training with materials approved by Quality.
  • Responsible for follow ups on all related Operational findings from FDA, other regulatory bodies, contract customers, internal audits, etc.
  • Room checklist and logbook program oversight in accordance with approved SOP’s.
  • Leadership for and conducting of daily walk-throughs for GMP potential concerns; and subsequent reporting and tracking to closure.
  • Assures area management is accountable for compliance at all times with direct, independent reporting relationship to site head.
  • Follow up and support investigations assigned to site Operations.
  • Conduct weekly facility walk through evaluations with facility maintenance
  • Review employee practices for proper aseptic techniques, including media fill videos.
  • Provide daily oversight to Production Supervisors and Team Leads of all documentation within the formulation, filling and packaging departments. This is to assure effective detection and real-time corrective action of operator errors.
  • Conduct aseptic behavior training in concert with Quality.
  • Assist in media fill program and observer role.
  • Standing member of site Technical Review Board.
     
 
EDUCATION AND EXPERIENCE:
 
  • Bachelor Degree in Scientific Discipline or equivalent combination of education and experience
    • 5 years minimum work experience in Aseptic Manufacturing for a FDA regulated and
      approved facility
    • Excellent oral and written communication skills
       
      JOB PREREQUISITES:
       
  • Ability to meet attendance standards.  All full-time employees are required to work a 40 hour week, most of which has to be during “regular” business hours. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.
  • Hands on experience required to manage and trouble shoot major projects.
  • Have a thorough knowledge in applicable FDA/cGMP and ICH guidelines.
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!

This position does NOT provide sponsorship so please do NOT apply if you require sponsorship.  Thank You

KP Recruiting Group 
"Bringing Talent to the Marketplace"

KP Recruiting Group is a well established and very respected recruiting firm.  We have built a strong reputation as a premier resource for providing highly qualified candidates for our clients.  We are very experienced in many industries and have a wide range of clients.  We will serve as your advocate during your career search!  Let us do the work for you!  There is never a fee for our services!



 
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