Quality Assurance (QA) Manager - FDA
FMC Corporation - Green River, WY

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External Overview:

Quality Assurance (QA) Manager – FDA

FMC employs people across a broad range of occupations in locations across the world where we use advanced technologies in research and development, mining, and manufacturing to produce customized products and applications. Our offerings provide important sustainable benefits, including increased agricultural production, better foods and medicines, advanced energy storage, and cleaner water, air and soil.

FMC employees enjoy competitive compensation, a menu of work/life benefits and opportunities to continue developing their skills and building their career. FMC is an Equal Opportunity Employer, EEO, AAE, MFDV and supports a drug-free workplace. If you are ready to make a difference every day, FMC is ready to talk to you.

FMC Green River, WY is hiring an experienced QA Manager – FDA. Are you ready for a hands-on leadership role solidifying and leading FDA compliance? Our Bicarb Plant manufactures many of our regulated products under the Q7A guideline. ISO9000 regulates our facilities including the Bicarb plant.

You can challenge yourself with the exciting task of creating a Quality Unit surpassing current industry standards.
  • Responsible for documentation, procedures, standards and upgrading the QA Management system; with shared responsibility for managing the ISO 9000 certification and GMP coaching across all plants (continuous bulk production)
  • Resident expert for Q7A and QA for products used in feed, food, and API
  • Primary contact for regulatory agencies
  • Manage two direct reports; a customer complaint coordinator and a QA team member
  • Responsible for supplier audits and work closely with the Lab and plants

Our Green River, Wyoming plant is the world’s largest trona mine and producer of natural soda ash. Manufacturing a variety of feed grade, food, and API products (soda ash, sodium bicarbonate, sodium hydroxide) for food and pharmaceutical, glass, environmental, household products, mining, oil & gas, and more.

If this challenging role is right for you, apply now to be considered.

Responsibilities:
  • Manages the Green River quality management systems; ensuring they meet internal and external customer expectations.
  • Ensures compliance with product safety regulatory requirements including approval of quality and food safety related change management
  • Management Team representative in quality related agency interactions with the Green River plant
  • Ensures product claims and specifications are up-to-date and in accordance with applicable regulations and customer requirements.
  • Ensure quality incidents are properly reported and investigated.
  • Drive continuous quality improvement initiatives at the Green River site.
  • Participate in new process development or major modification efforts (for new or modified products) to determine the impact upon quality.
  • Management representative for the ISO 9000 system
  • People development and performance management of direct reports
  • Main interface with the Law/Communications Departments for communications on the website and to customers relating to Product compliances.
  • Manage Improvements and Changes in Product related Regulatory Compliance
  • Ensure that all quality action items are completed in a timely manner whether arising from follow-up to a quality incident, a customer quality audit, an internal or external ISO audit, an internal quality process improvement process, or other source.
  • Lead site ISO 9001 maintenance and re-certification efforts
  • Reply to customer questionnaires relating to the business
  • Train production areas to ensure compliance with all Product related certifications
  • Support Responsible Care program
  • Develop and administer salary plan for direct reports
  • Ensure that employees within area develop skills and capabilities to meet the needs of the business
  • Provide necessary support and resources to the ISO 9000 system

Bicarb Plant Focus
  • FDA/Food Safety Expert
  • Leader of the Food Safety Team
  • Quality Unit sign off on all Hemo and USP shipments
  • Coordinate Mock Recalls
  • Approve Bicarb Controlled Documents
  • Approve Quality portion of the Supply Chain’s Distribution and Transloading systems
  • Provide training on Q7A cGMP for Alkali Chemicals Division
  • Forward looking into the Q7A CGMP changes
  • Forward looking into the USP changes
  • Lead internal audits for the FDA and other product related certifications.
  • Key participant in the FDA audits/visits and any other Quality/Food Safety agencies
  • Manage compliance with applicable regulatory and company standards, regulations and policies
  • Maintain and expand knowledge product regulations especially in FDA and USP areas

Required Education:
  • BS in Food Science, Chemistry, Bio-sciences or related

Qualifications:

Required
  • BS in Food Science, Chemistry, Bio-sciences or related
  • Minimum 5 years experience managing QA for food and / or bulk pharmaceutical excipient, manufacturing; 10 years preferred
  • Minimum 5 years supervisory experience

Preferred
  • Bulk continuous process manufacturing experience
  • Q7A
  • Kosher
  • Hallal
  • AWWA
  • API
  • NSF
  • Feed grade
  • Food

Apply Now

QA, “quality assurance”, Q7A, FDA, Hallal, Kosher, Parve, AWWA, API, feed, “feed grade”, food, bulk, excipient, “continuous process”, pharmaceutical, pharma, Food Science, Chemistry, Bio-sciences

FMC Corporation - 2 years ago - save job
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E may = mc 2, but FMC = chemicals. Once in areas as diverse as oil field equipment and food machinery, FMC Corporation now focuses on...