POSITION SUMMARY. The primary purpose of this position is to oversee the compounding operators ensuring their activities and respective areas meet the specifications outlined in the batch record. This includes but not limited to following safety, quality, Standard Operating Procedures, cGMP requirements and Work Instructions within the department. DUTIES & RESPONSIBILITIES. (Duties may include, but are not limited to, the following). The Compound...
We are seeking a detail-oriented Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong background in compliance management, FDA regulations, and quality assurance within the pharmaceutical or medical device industry. Responsibilities. Labeling & Artwork Compliance. Conduct label proof reviews and approvals for new and revised artwork. Approve shipment labels and ensure printed materials meet FDA, FTC, and customer...
