• · Review and approve/reject all raw materials and packaging components.
• · Respond to customer complaints.
• · Administer/review complaint investigations.
• · Review all investigations as necessary.
• · Create change controls.
• · Revise all packaging and manufacturing batch records.
• · Review and approve monographs, specification sheets, and analysis sheets.
• · Handle all quarantine shipments.
• · Audit manufacturing processes.
• · Review and approve new labeling.
• · Coordinate recalls.
• · Review warehouse temperature monitoring data and charts.
• · Support and provide assistance to the Quality Assurance Manager as necessary.
• · Perform investigations, determine root cause, and develop CAPAs

Required Skills/Abilities:

• · Excellent verbal and written communication skills in English.
• · Excellent management and teamwork skills.
• · Excellent organizational skills and attention to detail.
• · Excellent time management skills with a proven ability to meet deadlines.
• · Ability to function well in a high-paced and at times stressful environment.
• · Ability to understand and follow all Standard Operating Procedures and current Good Manufacturing Practices provided by the Company.
• · Understanding of quality systems including change control, deviations and CAPAs.
• · Ability to handle multiple tasks concurrently and complete them in a timely manner.
• · Strong written and verbal language skills to effectively read and write SOPs and related lab reports, and communicate with personnel at all levels in the organization.