Get to know us

My career has spanned almost 50 years beginning with Norwich-Eaton Pharmaceuticals ( Norwich, NY, Brantford, Ontario and Greenville SC), Carter Wallace laboratories ( Decator IL), Cumberland Swan ( Smyrna, TN),  Perrigo (Allegan MI), Banner Pharmacaps ( High Point NC), Herbalife ( Los Angeles, CA) and Pharmachem Laboratories ( Kearny, NJ).

All of the positions involved managing Quality Control, Quality Assurance, Documentation Control responsibilities relative to Plant GMP Compliance ( Prescription, OTC, Dietary Supplement and Food categories). In most cases the responsibilities were US multi-plant locations. I have also had experience interacting with regulatory agencies in Mexico, Brazil, Canada and China.

The overall responsibilities covered quality systems associated with the following areas:

  • Receiving, Testing and Release of Raw Materials, Finished Product and Packaging components
  • Development of Raw material, Finished product and Packaging component specifications
  • Warehouse controls associated with received components
  • Development and approval of Master Manufacturing, Production and Packaging Batch Records
  • Cleaning and Sanitizing of Manufacturing and Packaging Equipment
  • Environmental Monitoring
  • Training Programs
  • SOP Development and approvals
  • Complaint Programs
  • Returned Goods
  • Recall Procedures
  • Raw Material Supplier Qualification program
  • Third Party Laboratory Verification and Approvals
  • Internal and External audit programs
  • Handling of FDA Audits
  • Handling of Third Party Audit Programs ( NSF, FSSC 22000)
  • Pest Control program
  • Calibration Programs

The hands on experience at the plant level early in my career and later providing management direction to quality and operations departments has allow me to implement a very practical interpretation of applicable regulations which results in quality systems that minimize compliance challenges.

I have been directly involved in FDA GMP inspections of many US facilities. This participation included during the audits, post inspection exit discussions and finalizing responses to any FDA-483 observations that may have been noted.

Joseph E. Mitchell, Jr. Ph.D.
Joseph E. Mitchell, Jr. Ph.D.Owner
Villanova University – Bachelor of Science in Chemistry
University of Rhode Island – Ph.D. Analytical Chemistry

I had the pleasure to work with Joseph Mitchell during the 2019-2020 period. I found Joe to be well prepared technically, with great business acumen, on almost every subject matter within the dietary supplement industry. This included; test methods, operational procedures, certifications, regulations, process understanding and specifications. Most of all, I found Joe’s interpersonal attentiveness to be above expectations. I may be speaking on behalf of many, but everyone I know of whom has worked with Joe, valued and enjoyed the experience.

Even under the most stressful of times to achieve company targets, launch dates or other deadlines, Joe made the challenge both a learning experience and enjoyable. We solved problems, achieved deadlines and goals together, as a team. He united us cross functionally and we felt we could achieve almost anything, and we did.

The words I think of when considering Joe’s strengths are; integrity, trust, a resource, always willing to listen, open-mindedness, collaborations, enjoyable, goal oriented, customer focused and people caring.

Any organization, project or assignment would benefit in the hands of Joe Mitchell.
My team and I were lucky to have worked with him and for which we are grateful.

Craig Stapleton - Quality Manager, Innophos