QA Manager-Direct Hire-Pasadena, TX

Kelly Scientific Resources is recruiting for a direct hireQuality Assurance Manager for a Dietary Ingredient Manufacturing Plant in Houston. The QA Manager will be responsible for ensuring plant and company compliance with the Food CGMP (21 CFR Part 110) and the Dietary Supplement CGMPs (21 CFR Part 111), including direct supervision of all Quality Control Testing and Laboratory Operations.DUTIES AND RESPONSIBILITIES: Review/approve the following documents prepared by the Production, Technical, Engineering, Maintenance, and Quality Units: Master Batch Records; Specifications, Sampling Schedules, and Quality Control Test Methods; Records of Education and Training; Batch Production Records and Laboratory Test Records; Deviations, Investigations, and OOS reports; Analytical Test Method Validations; Plant Equipment Verifications, Internal and External Audit Reports (Supplier Evaluations) Customer Complaints, Change RequestsResponsible for the following items:Managing a CGMP and OSHA/PSM compliant Change Control system;Releasing or Rejecting all Finished Products;Verifying the consistency of the manufacturing process by product quality review;Verifying by internal audit the CGMP compliance of all departmentsEvaluating and approving contract manufacturers (including contract laboratories) and suppliers of raw materials by performing external audits and reviewing quality questionnairesProvide GMP education and training to all plant employees;Hosting Customer and Regulatory AuditsReturn and Recall HandlingQUALIFICATIONS:Required:Degree in Chemistry, Microbiology, Biology, or other related scientific fieldAt least 5 years experience in the field of Good Manufacturing PracticesExperience in hosting customer and regulatory auditsExperience in maintaining a GMP compliant Quality System for a Manufacturing site.Preferred:Language skill in Japanese a plus.5 years experience in a Dietary Supplement or Dietary Ingredient Manufacturing EnvironmentThorough understanding of Food GMPs, Dietary Supplement GMPs and API GMPsThorough understanding of US, Canadian, and EU regulations for the manufacture of a Dietary Ingredient.Regulatory Audit Experience Learn more about company