What are the responsibilities and job description for the QA Regulatory Compliance Specialist position at J W Nutritional?
Job Details
Job Location
JW Nutritional LLC McKinney - McKinney, TX
Description
QA Regulatory Compliance Specialist
Duties :
Review and approve all MMRs and BPRs prior to production.
Perform QA review of testing result packets from the lab.
Control labels.
Create and edit finished product specifications, COAs, etc.
Coordinate calibration of scales and balances for production. Review and file calibration results.
Review completed BPRs, as needed.
Review all raw ingredient, component, and finished product test results.
Provide customer service. Gather ingredient data and statements as required to support label claims, such as non-GMO, all natural, etc.
Assist with personnel training, as needed.
Regulatory compliance in accordance with FDA 21 CFR 111 guidance.
Identify nonconformances, perform investigations, and implement CAPAs, as necessary.
Provide label compliance expertise to customers.
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.
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.
Assist with interviewing and selection process of new hires for department, ensuring that non-discriminatory laws and guidelines are followed.
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 supervisory and managerial duties as needed / requested by senior management.
Reports To : QA Regulatory Compliance Supervisor
Working Condition :
Quality Assurance covers all areas of the facility and manufacturing.
Qualifications
Education / Certification :
Bachelors degree and / or relevant background
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
