United Exchange Corporation is an established and fast-growing manufacturer/distributor of health and beauty care consumer products. UEC is seeking an Assistant Quality Manager to maintain the quality control program and lead a growing company to ensure consistent quality and integrity of the final product.

Duties and Responsibilities include, but not limited to:

• Responsible for supporting the process of incoming products from contract manufacturers, overseeing QA/QC activities.
• Manage the quality control testing of products from CMOs at contract laboratories.
• Assist in preparation of QC specifications, review/creation/approval of certificates of analysis.
• Support product batch record reviews and evaluation process.
• Coordinate the disposition of outsourced finished products in a timely manner.
• Hands on management and support of QA activities including but not limited to batch clearance, quality hold and destruction processes.
• Conduct investigations (including customer complaint investigations), and root cause analysis.
• Initiate and implement CAPAs to address findings, issues and non-compliances in the facilities.
• Author and revise SOPs, protocols, forms, and work instructions as required.
• Assure that Quality complies with cGMP, and other regulatory and industry standards.
• Continually evaluate quality systems supporting cGMP operations for potential improvements.
• The manager shall work with CMOs, contract laboratories, supply chain, regulatory personnel and with external counterparts at contract organizations to ensure compliance with the company quality policies, and documentation associated with development, manufacture and distribution of commercial products as per requirements of 21CFR Part 210/211/820, and ICH guidelines.
• Adhere to applicable SOPs and ensure that cGMPs are practiced.
• Support all aspects of Supplier Quality Management Program including supplier qualification audits/assessments, product quality assessments, develop/approve Quality Agreements and maintenance of the Approved Supplier List.
• Ensure that contracted suppliers comply with GMP/GLP regulatory requirements and relevant SOPs.
• Alert line management of significant quality, compliance, supply and safety risks, often requiring the coordination of activities across organizational units. Exercises independent judgment.
• Perform and manage training of internal personnel to permit execution of required tasks and ensure compliance to regulatory requirements/policies/SOPs.
• Develop and prepare quality data/metrics for Management Review
• Maintain up-to-date knowledge of cGMP regulatory issues, industry and affiliated publications, standards and guidance.
• In-depth understanding and working knowledge of FDA and pharmaceutical cGMP regulations.
• Ensure Quality operations are at a state of inspection readiness.
• Participate during FDA inspections and internal audits.
• Must be detail oriented, possess excellent time management skills, be well organized, a self-starter and display a professional demeanor with a high focus on quality and compliance.
• Possess leadership skills with the ability to develop employees and maintain an atmosphere of growth and achievement; a self-starter with minimum oversight required to accomplish goals.
• Must possess excellent communication and technical writing skills, strong interpersonal skills and the ability to work with others in a positive and collaborative manner; able to communicate with a sense of urgency to internal and external customers.
• Proficient in Word, Excel and PowerPoint with the ability to promptly learn and master inventory system/regulatory/compliance software.