Create and Maintain production and lab validations in an FDA registered OTC and/or personal care/cosmetic environment. Provide training and build systems, track CAPA (Corrective and Preventive Actions) systems and support FDA/Customer audits.
Support in the development of proper specifications for equipment and processes through validations and/or qualification.
Foster Compliance and continuous quality improvement to meet and exceed customer expectations.
Perform validations with a specialty in Process, Equipment, Lab, Cleaning, Facilities and Computers.
Assess and identify employee training programs and interact with Human Resources to develop and implement training; the logic and requirements behind our systems, the regulatory requirements for various job functions.
Manage system of internal compliance audits. Perform follow-up and support to appropriate teams to ensure adequate corrective actions are documented, implemented and measured for effectiveness.
Create/update SOP's (Standard Operating Procedures); train other employees on how to effectively write SOP's.
Create and maintain documentation control system
Conduct GMP (Good Manufacturing Practices) training.
Track CAPA (Corrective and Preventive Action) items.
Participate and support client and FDA audits.
Perform other related duties as assigned.
Thorough practical experience in validation/qualification, statistics, communication, motivation and assessment.
Ability to exercise independent judgment and initiative. Detail oriented with impeccable organizational skills.
Ability to interact with all levels within the corporate structure.
Communicate effectively using English verbal, written and communication skills.
Computer literate in all basic Microsoft programs; Outlook, Excel, Word, Outlook.
Education and Training:
BS/BE Degree - technical (sciences or engineering) or equivalent experience. Professional certification by ASQ or similar body a plus. Minimum 5-7 years hands on, non-management experience.
Prior work experience within the personal care (hair, body and face) products will be helpful in fulfilling the requirements of this position.
ChemAid Laboratories is a contract manufacturer of prestige Personal/Body/Hair Care products. We offer a competitive benefits package.