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Quality Assurance Manager

  • Full Time, onsite
  • Indenovo Global Search & Selection
  • Chicago, United States of America
Salary undisclosed

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Overview:

Role: QA Manager

Location: Chicago, Illinois

Salary: $120,000-$130,000

Manage and coordinate activities and operations of Quality Assurance throughout the facility and oversees the Quality Assurance Analysts. Performs duties which support the company’s QA and operational key indicators as well as verify all products meet Food Safety standards and include HACCP, Organic, Gluten Free, Kosher, Halal, non-GMO, and NSF and SQF Certification (GFSI) standards.

What we expect from you:

  • Primary SQF Practitioner to ensure SQF code provisions are met to meet the Company SQF certification.
  • Manage the maintenance of quality systems and facilitate continuous quality improvements.
  • Manages compliance to NSF standards under 21 CFR part 111 and 117.
  • Manages HACCP and Food Safety programs as a PCQI trained individual.
  • Support internal, external, and third-party audits in accordance with GMP regulations, industry best practices, standard operating procedures, and quality policies.
  • Develop appropriate responses to internal audit observations (CAPA).
  • Create and manage CAPA reports as needed.
  • Update Food Safety and HACCP plan as needed.
  • Stay current with changes to current Good Manufacturing Practices, including FDA, EU, CN, and other regulatory bodies and guidance bodies including SQF and NSF standards so that Research compliance policies are current and effective.
  • Assists and supports Food Defence program.
  • Manage the Company training program.
  • Hold or Assist trainings on GMP, HACCP, Food Safety and other plant quality trainings as needed as well as maintain training records/matrix.
  • Manage the Company Vendor Qualification program.
  • Manage Supplier Score Card program, working closely with Purchasing on a consistent basis.
  • Manage the Company Complaint program
  • Support the creation, review and updating of SOPs and other controlled documents
  • Review, create and/or assist with In-Process/Reprocess documents.
  • Manage Change Control Requests (CCRs) through the change control process and verification of successful completion of CCRs.
  • Manage the implementation and maintenance of the deviation program/report process including trending and presenting data on a routine basis for process improvement.
  • Manage the approved raw material and finished goods specification paper and electronic files.
  • Maintain current knowledge of government and industry compliance standards.
  • Collaborate with Research and Development personnel during new product start-ups and support the establishment of key checkpoints for new products and processes.
  • Manage the Quality Analyst’s review and disposition of finished products for distribution.
  • Oversee Quality label review and compliance to company defined expectations.
  • Provide day-to-day management, guidance and oversight of the Quality Assurance team and actively work to promote and recognize performance.

What you will need:

  • Bachelor’s degree (B.S.) in related field or equivalent required, master’s degree preferred
  • Four to six years related experience or equivalent
  • Strong knowledge of nutritional manufacturing processes, computer, and equipment validation, GMPs, and product/process validation
  • SQF Practitioner Certification required
  • PCQI certified
  • HACCP certified
  • Knowledge of and ability to utilize statistics in evaluation and trending of data
  • Thorough knowledge of FDA regulations
  • Experience with laboratory environment, equipment, and safety procedures
  • Experience in research and development, including understanding of statistical analysis
  • Demonstrated proficiency in supervising and motivating subordinates
  • Commitment to excellence and exacting standards
  • Excellent written and oral communication skills
  • Strong organizational, problem-solving, and analytical skills
  • Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
  • Acute attention to detail and assist in streamlining procedures and improve document and workflow
  • Proficient on Microsoft Word, Excel, Power Point, Outlook and MRP software,
  • Proven leadership and business acumen skills
  • Proven ability to manage multiple projects and meet deadlines
  • Ability to deal and communicate effectively with a diversity of individuals at all
  • organizational levels
  • Working knowledge of data collection, data analysis, evaluation, and scientific method
  • Ability to develop clear, concise, and timely oral and written reports