FDA Program Manager - #9820196

Harcros Chemicals Inc.

Date: 1 week ago
City: Kansas City, KS
Contract type: Full time
FDA Program Manager SUMMARY Harcros Chemicals Inc. is an employee owned company with a century in specialty chemical manufacturing and distribution. We currently have 2 manufacturing plants and 27 distribution facilities in 20 states. As we continue to grow, we are looking for an FDA Program Manager to support regional distribution and manufacturing facilities. The main focus of this position is to perform regulatory compliance for the company with an emphasis on FDA compliance at all affected Harcros facilities ESSENTIAL DUTIES AND RESPONSIBILITIES
  • Ensure compliance with the Food Safety Modernization Act (FSMA).
  • Authoring and maintaining Food Safety Plans for each facility manufacturing, processing or storing food grade products.
  • Review and keep current SOPs related to food safety.
  • Manage training for FDA regulated facilities.
  • Identify and mitigate facility quality and compliance risks related to FDA compliance.
  • Respond to Agency audits for food facilities.
  • Respond to customer audits and surveys related to food compliance.
  • Implement and maintain SQFI registrations.
  • Conduct evaluations on food grade chemicals.
  • Review existing food grade products on a regular basis to ensure up to date compliance.
  • Review new food grade products and ensure that they are suitable.
  • Ensure that all documentation and product labeling of food grade products is in compliance with FDA requirements.
  • Manage Foreign Supplier Verification Program (FSVP).
  • Provide support to Harcros personnel regarding FDA regulatory compliance.
  • Employee may perform other risk management & regulatory related duties as needed by the organization.
  • Other duties may be assigned.
QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions EDUCATION and/or EXPERIENCE Must have a Bachelor's degree (B.S.) from four-year college or university, preferably in Chemistry, Engineering, Industrial Hygiene, Biology, science based degree or equivalent combination of education and experience. Must have a good knowledge of chemistry and food regulations as well as five to ten years of FDA compliance experience. Extensive knowledge of food safety, 21 CFR, FSMA regulations, and cGMP is required LANGUAGE SKILLS Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
MATHEMATICAL SKILLS Ability to apply advanced mathematical concepts necessary for calculating the classification of chemicals. Must be able to calculate percentage and convert to parts per million REASONING ABILITY Ability to define problems, collect data, establishes facts, and draw valid conclusions OTHER SKILLS AND ABILITIES
  • Ability to use a personal computer with working knowledge of word processing, and spreadsheet software.
  • Familiarity with safety and environmental law is a plus.
  • Experience in techniques of training technical and professional courses.
  • Be able to work with a variety of backgrounds in order to building effective teams.
  • Occasional travel may be required for training or other job related duties.
PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions While performing the duties of this job, the employee is regularly required to sit. The employee frequently is required to stand; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions Harcros Chemicals is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against based on their race, gender, sexual orientation, religion, national origin, age, disability, veteran status, or other protect classification.

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