732-661-0400

QA Document Control

  • Location: DFW
  • Type: Contract To Hire
  • Job #37897

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

ESSENTIAL DUTIES AND RESPONSIBILITIES:
• 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 Art work 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 reregistration.
• Assists with facility GMP audit reports as assigned by the 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 trainings.
• 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 draw sound conclusions.
• Reports quality and/or safety trends and potential issues to Quality management and participate 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 QA manager.

SUPERVISORY RESPONSIBILITIES This job has no supervisory responsibilities.

EDUCATION and/or EXPERIENCE High School Diploma or GED and some college (science based courses
preferred). Minimum 3-year of hands-on experience as Quality Control, Quality Assurance documentation in
cGMP environment; preferably in a pharmaceutical, nutraceutical or food manufacturing industry. Experience
with document control, batch record, product specification 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 writings. Ability to write reports, business correspondence. Ability to effectively present
information and respond to questions from departmental manager/supervisor or other employees.
MATHEMATICAL SKILLS Ability to apply simple mathematical operations to such as calculating average
of numbers, fractions, percentage, variation, etc.
COMPUTER SKILLS To perform this job successfully, an individual should have proficient knowledge of
Database software; Spreadsheet software and Word Processing software such as Microsoft Word, Excel and
archiving software.

Attach a resume file. Accepted file types are DOC, DOCX, PDF, HTML, and TXT.

Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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