Quality Assurance Supervisor

Lewes, DE

Summary of Responsibilities:

As a leader of the Quality Assurance group you will supports the site activities to ensure that the site follows all Federal, State and company managed quality compliance programs with emphasis on proper (current- General Manufacturing Practice) (cGMP) documentation, investigation writing and (cGMP) auditing by:

  • Ensuring site awareness of quality standard operating procedures (SOPs) and good manufacturing practices (cGMP) regulations.
  • Acting as a Liaison with production as a representative for the quality program with special emphasis on proper (cGMP) documentation and auditing.
  • Performing investigation management, independently investigating, resolving and negotiating corrective and or preventative actions (CAPA) with site manufacturing and other functional groups within the site.
  • Overseeing the completion of the Annual Product Reviews (APR’s) to ensure adherence to the schedule.
  • Support and at times lead auditing activities at the site.  This includes internal and customer audits as well as inspections by regulatory agencies.
  • Supervising QA group with regards to paid time off (PTO) scheduling, performance management and disciplinary actions.

The candidate should be results oriented, self-motivated, open to change, customer focused and forward thinking.

Experience and Education Requirements:

Bachelor’s degree in a Science field and/or at least 6 -10 years of equivalent work experience within the pharmaceutical or chemical industry.  Experience with Quality systems such as (cGMP) documentation review/approval, auditing, product and raw material release, change control, investigations, and training is critical.  An understanding of chemistry is desirable.