QA Batch Record Coordinator-1 (Atlanta, GA)

| Atlanta, GA
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Job Description:

The Batch Record Review Coordinator ensures 21CFR820, ISO Compliance, overall data integrity for lab results (e.g., testing of raw material, formulation materials, and in-process samples, standards and international components for the production of contact lenses) and analytical results. Reviews Device History Records for all JCM LS3 products, including analytical results, formulations, saline, and phosphate materials, to ensure documentation meets procedural and regulatory requirements. The Batch Record Review Coordinator is responsible for ensuring accuracy, completeness, and adherence to SOP's and FDA, GMP policies and regulations.

Key Requirements:
  • Manufacturing Quality: Validation Support work includes:
  • Performing analyses, inspection, and tests of raw materials, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance to customer and regulatory requirements, and tolerance specifications for the chemical or physical property• Performing a variety of qualitative tests or qualitative assays on samples to aid in maintenance and certification of test instruments and apparatus to ensure compliance• Performing required inspections, checks, analysis and documentation of studies• Preparing and monitoring quality statistics and reports
    Reviewing production records for conformance to procedures• Conducting non-conformance tests of manufactured, packaged or tested product• Evaluating non-conforming results and initiating re-sampling, re-testing, and/or hold procedures

Minimum Qualifications:
  • High School Diploma
  • The ability to fluently read, write, understand and communicate in English
  • 1 Years of Relevant Experience in Manufacturing
  • H Shift- Day Shift
  • Relocation assistance: No
  • Sponsorship available: No

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to [email protected] and let us know the nature of your request and your contact information.
More Information on Alcon
Alcon operates in the Biotech industry. The company is located in Irvine, CA, Lake Forest, CA, Fort Worth, TX, Houston, TX and Duluth, GA. Alcon was founded in 1945. It has 20962 total employees. It offers perks and benefits such as Flexible Spending Account (FSA), Disability Insurance, Dental Benefits, Vision Benefits, Health Insurance Benefits and Life Insurance. To see all 31 open jobs at Alcon, click here.
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