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Quality Assurance Manager

2 months ago

Dallas, United States Regal Professional Services Full time

Regal Professional Services is seeking to hire a Quality Assurance Manager with cGMP background for a manufacturing facility in the South Dallas area.


Summary:

The Quality Assurance Manager takes responsibility for the planning, scheduling and supervising of all the Quality Assurance processes and personnel in the QA/QC Department.


Responsibilities:

  • Promotes and enforce GMP, GDP, Food Safety, FDA regulations and company policies.
  • Performs Monthly Internal GMP audits at all company departments, including production, QC, R&D, maintenance etc. and generate monthly GMP reports.
  • Administer the change control on company documents (SOPs), manufacturing (batch records) and regularly procedures and ensure that appropriate training is documented and only the most current revisions are in use.
  • Issues new documents (SOPs, test methods, test sheets, batch records, master formula and spec sheets). Update and/or change documents as required and assures documents accuracy.
  • Review production paperwork and batch records by checking and auditing the documents for accuracy and completeness, calculate production yield and ensure compliance with the established specification limits.
  • Ensures that the established QA/QC procedures are followed.
  • Ensures that good documentation practices and good manufacturing practices are followed.
  • Assists with FDA, ISO, NSF, Kosher, Halal and other external audits.
  • Leads product failure and customer complaint investigations and maintain Customer Complaint and Material Non-Conformance files.
  • Oversees the equipment and instruments calibration and preventive maintenance program.
  • Maintains environmental and pest control programs.
  • Maintain and track the status of manufacturing investigations, laboratory investigations, special projects, customer complaints, process and document changes, CAPAs, risk assessments, vendor qualifications, etc. Prepares the annual product review reports and maintain appropriate files.
  • Coordinates employees training program and oversee the completeness of employees training records.
  • Assists in development and updates in company’s Food Safety and Food defense plans, HACCP, process control and monitoring procedures.
  • Stays up to date with current CFR pertaining to food, dietary supplements, cosmetic and drugs.
  • Maintains Quality Assurance records and documents organized, audit ready and easily retrievable.


Qualifications:

  • Bachelor's degree (B.A.) from a four-year college or university
  • 7-10 years related experience in progressive QA/QC leadership roles
  • Expert knowledge in cGMP practices, GDP, Food Safety, FDA regulations, FSQA, HACCP
  • Database software; Manufacturing software; Spreadsheet software and Word Processing software. Knowledge of Oracle is a plus.