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Quality Assurance Analyst - Midlothian, United States - The Sunrider Corporation
Description
Job Description
Job DescriptionSUMMARY Responsible for directing QA employees to perform the duties associated with QA activities and document control.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Essential duties are performed with minimal supervision.
•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.
•Promotes and enforce GMP, GDP, Food Safety, FDA's and company policies. Performs Monthly Internal GMP audits in all TXP departments, including production, QC, R&D, maintenance etc. and generate monthly GMP reports.
•Assists with FDA, ISO, NSF, Kosher, Halal and any other external audits.
•Assists in investigation of product failures and customer complaints as necessary and maintain Customer complaint files.
•Oversees the equipment, instruments and tools calibration program. Maintains environmental and pest control programs. Assists with and track the status of manufacturing investigations, laboratory investigations, special projects, customer complaints, process and document changes, CAPAs, risk assessments, vendor qualifications, etc. Assists in preparations of the annual product review reports and maintain appropriate files.
•Coordinates employees training program and oversee the completeness of employees training records. Assists in development of 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.
•Other tasks and functions as assigned by QA/QC manager.
SUPERVISORY RESPONSIBILITIES This job has no supervisory responsibilities.
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 Bachelor's degree (B.A.) in a scientific discipline from four-year College or university. Should have 3 + years of experience in Quality Assurance. Experience with batch record review, CAPA and customer complaints investigation, deviation and rework procedures. Should have experience working on the floor of a manufacturing facility.
LANGUAGE SKILLS Ability to read, analyze, and interpret 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 departmental manager/supervisor or other employees.
