• Daily operations include:
  • Regulatory Affairs, or
  • Quality Unit and Order Entry
• Interact with all levels of the company, customers and regulatory agencies.
• At least partial responsibility for training all personnel in the above area; and other departments.
• Writing, updating and enforcing (in conjunction with the Quality Unit and other departments) procedures, including S.O.P.’s.
• Interact with third party laboratories for testing of registered and R&D formulations.
• Perform other duties as assigned.

Work experience requirements

• Experience with EPA-based Antimicrobial, or pesticide, matters strongly preferred
• Experience directing testing of EPA registered antimicrobial pesticide strongly preferred.
• Experience as Management of Regulatory Affairs or equivalent posittion.
• Two or more years experience with the requirements of cGMP.
• Two or more years experience with one or more computerized ERP systems preferred.
• Five or more years experience with computerized word processing and spreadsheet programs, preferably MS Office software.

Education requirements

• Bachelor’s Degree preferred.

AREA OF RESPONSIBILITY

• The Regulatory Affairs Department’s responsibilities include:
  • Approving all SOP’s.
  • Approving all company policies that are subject to review and/or enforcement by government regulatory agencies such as the EPA, FDA & USDA.
  • Maintain currency on all regulatory issues (EPA/FDA-related) that the company is subject to.
  • Be the company’s primary representative to all agencies such as the EPA & FDA.
  • Interfacing & Guiding the company’s Distributors and other direct customers in their responsibilities and requirements necessary to satisfy the EPA & FDA.
  • Reviewing all (Company’s, Distributor’s and other direct customer’s) labels and marketing materials for compliance with appropriate regulatory agencies’ requirements.
  • Ensuring regular training of personnel is performed.
  • Process new Distributor Applications.
  • Directing required testing of registered and R&D formulations in compliance with EPA guidelines

• The responsibilities of the Quality Unit include:
  • Approving or rejecting all components, product containers, closures, in-process materials, packaging material, labeling and products.
  • Reviewing production batch records to assure that no errors have occurred, or if errors have occurred, that they have been fully investigated.
  • Approving or rejecting products manufactured, processed, packed or held under contract by another company.
  • Approving or rejecting procedures or specifications that will affect the identity, strength, quality and purity of products.
  • Approving all specifications and master production instructions.
  • Making sure that internal audits (self-inspections) are performed.
  • Approving intermediate and API contract manufacturers.
  • Approving changes that potentially affect intermediate or product quality.
  • Reviewing and approving validation protocols and reports.
  • Making sure that quality-related complaints are investigated and resolved.
  • Making sure that effective systems are used for maintaining and calibrating critical equipment.
  • Making sure that materials are appropriately tested and the results are reported.
  • Making sure that there is stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates, where appropriate.
  • Performing product quality reviews.