Quality Manager

Panacea Biomatx Inc. an exciting new startup company that delivers personalized daily dietary supplement packets using a patent pending automated process, is looking for a Quality Manager. Panacea is currently transitioning from late-stage R&D to early-stage production. Position will begin as part time employee with potential to grow into a full time role. A suitable candidate would possess the skills, knowledge, and experience to facilitate this transition. As production grows and responsibilities increase the candidate would be eligible to transition full time.

RESPONSIBILITIES
  • Oversees and manages the on-site Quality program for the facility.
  • Must approve all plant procedures and any changes that may affect the Quality of the product.
  • Has the authority for final release of all products for distribution.
  • Maintains all regulatory documents including FDA registration, licenses, DMF, CEP and site SOPs.
  • Oversee and coordinate daily workload to ensure timely release of finished goods.
  • Manages/coordinates flow of documentation from Production depts. to Quality dept. to ensure timely review of documents.
  • Manages and conducts plant-wide cGMP and food safety training to assure compliance with all regulations.
  • Trends data and reports potential problems to Management.
  • Coordinates all on-site regulatory and customer audits and provides written responses as necessary in a timely fashion. Also responsible for customer Quality surveys.
  • Coordinates the investigation of all customer complaints/dissatisfactions and provides written documentation including root cause and corrective and preventative action plans as required.
  • Responsible for auditing of both contract laboratories and processors including evaluation of proposed new and alternate raw material suppliers.
  • Helps develop and/or adopt new analytical methods to be used in the QC lab. Assists with laboratory analyses as needed.
  • Develops and implements new and/or improved programs to assure continual Quality improvements.
  • Manages the Quality department budget.
  • Performs other duties as assigned.
REQUIREMENTS
  • BS degree in Food Science, Biochemistry, Chemistry or other applicable degree.
  • Command of the regulatory requirements for dietary supplements, USP and EP requirements, and food safety requirements.
  • Two to five years’ experience in food manufacturing or dietary supplement manufacturing environment.
  • Good problem solving skills and interpersonal skills
  • Must have working knowledge of 21CFR 110 and 111 regulations and ICH Q7 Guidelines
  • Good written and oral communication skills
  • Ability to act independently and on one’s own initiative

To apply send resumes and cover letter to .

Panacea BioMatx, Inc. 615 Davis Drive, Suite 900 Morrisville, NC 27560