What are the responsibilities and job description for the QA Document Control position at J W Nutritional?
Job Details
Job Location
JW Nutritional LLC McKinney - McKinney, TX
Description
QA Document Control
Duties :
Control and reconcile labels.
Review completed batch production records.
Provide customer service.
Regulatory compliance in accordance with FDA 21 CFR 111 guidance.
Identify nonconformances, perform investigations, and implement CAPAs, as necessary.
Provide with label compliance expertise to customers.
File documentation appropriately.
Maintain the current Quality System and update as needed. Create and revise internal QA / QC documents.
Ensure and implement change controls and updates on finished product specification sheets as needed. Additional duties as required by direct management
Assist with third party audits.
Inspect and audit facility for cleanliness, organization, etc.
Inspect and audit employees to ensure current in-house SOPs are being followed.
Notify Operations and Quality Assurance / Quality Control management of significant problems.
Complete documentation necessary to attest to satisfactory completion of inspection.
Check facility for any cleaning issues; direct cleaning team to ensure overall facility cleanliness.
Enforce all of the above through employee warnings and / or write-ups.
Ensure that employee-training programs are completed on a timely basis.
Halt production, if necessary.
Perform a variety of other related job duties / assignments, or special projects, as required.
Support Company policies, procedures, and work-rules and ensure that department employees comply with policies, standards, and work-rules.
Counsel and discipline employees, as needed, to ensure compliance with Company policies, standards, and work rules.
Set a positive example of leadership to others throughout the organization; promote a leadership style that encourages open communication, positive team-building efforts and employee morale.
Performs other duties as needed / requested by senior management.
Reports To : QA Regulatory Compliance
Required Skills : Basic math skills
Basic communication skills
Working Condition :
Quality Assurance covers all areas of the facility and manufacturing.
Qualifications
Education / Certification :
Minimum high school diploma
Required Knowledge :
Proficient in all MS Office products
Required Experience
Strong organizational, analytical, and problem solving skills
Strong understanding of current FDA Good Manufacturing Practices (GMPs) for Dietary supplements.
Excellent oral and written communication and interpersonal skills
Bilingual : Spanish and English preferred
