QC Document Control Associate

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Personal - 5/8 Texas Location, Midlothian, TX, US

Salary Range: $18.50 To $19.00 Hourly

SUMMARY:

Responsible for maintaining Document Control Procedures and Practices. Provides assistance to the QC/QA Manager and Quality Assurance Department by performing the following duties.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Includes the following. Other duties may be assigned.

• Issue, review, updates company documents (SOPs), manufacturing (batch records) and regulatory procedures in accordance with company Document Control process. Keeps in order all relevant documentation files.
• Distributes all newly issued and revised documents to the appropriate/relevant users and departments.
• Keeps track of received data and source documents such as: QC Specification sheets for raw materials, bulks and finished products, Certificates of analysis and Safety Data Sheets.
• Works with other source documents such as: product formulas, vendor qualification documents, raw materials technical sheets, and product identification information to include and update part numbers, shelf life, etc. in Oracle inventory system when needed.
• Assists in the review and approval of the company Artwork files including but not limited to labels, boxes, jars and other primary and secondary packaging components.
• Helps prepare documents and certificates requested by legal department for product registration and re - registration .
• Assists with facility GMP audit reports as assigned by the QC/QA manager.
• Assists in the review and approval of production paperwork and batch records by doing Yield and Accountability calculations and checking the documents for completeness and accuracy in accordance with GLP and GMP practices.
• Maintains GMP training schedule for all company employees and keeps record of the completed training.
• Keeps records of Customer complaints investigations and OOS investigations and department’s Calibration and Validation activities. Fill out and complete the corresponding paperwork.
• Fills out deviations and rework instructions and issues them to the appropriate/relevant departments.
• Collects, tracks, trends and analyzes recorded data and draws sound conclusions.
• Reports quality and/or safety trends and potential issues to Quality management and participates in investigations as necessary.
• Maintains QA documentation (papers and e-files) well organized, up to date and audit ready.
• Participates in Quality System audits by helping to retrieve the necessary and relevant documents.
• Implements new and efficient ways to document and archive.
• Stay up to date with current CFR pertaining to food, dietary supplements, cosmetic and drugs.
• Other duties and tasks as assigned by QC/QA manager.

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:

High School Diploma or GED and some college (science-based courses preferred). Minimum 3 years of hands‑on experience as Quality Assurance documentation in cGMP environment; preferably in a pharmaceutical, nutraceutical or food manufacturing industry. Experience with document control, batch record review.

LANGUAGE

SKILLS:

Fluent in reading, writing and speaking the English language as well as having experience with technical writing (knowing Spanish a plus). Ability to read, analyze, and interpret technical instructions or…