Job Description

- Provides direct leadership for the Quality Control department in accordance with organizational policies and procedures and applicable industry regulatory guidance’s - Developing employees - Planning, assigning, and directing work - Meeting goals and performance standards, and driving continuous improvement - Responsible for creating an environment that encourages compliant efficiency, developing and coaching technical staff to improve skills, and ensuring high quality technical work - Maintain an understanding of all Quality Control and Safety SOPs - Supervise the daily testing and documentation review of raw materials to ensure accuracy and completion - Review change controls and out of specification reports - Review certificate of analysis to ensure compliance to applicable compendia (USP, NF, FCC, etc.) - Review new vendor and new item set-up submissions from purchasing department - Create/Update/Review Standard Operating Procedures (SOPs) - Conduct investigations (for internal and external customers), as well as provide guidance to team members on identifying root causes, while maintaining the highest safety, quality and GMP standards - Works interdepartmentally to identify corrective and preventative actions for deviations/out of specification reports - Supervise and evaluate the performance of team members - Participate/consult on Safety Committee - Assist Quality Management as needed in regulatory audits - Provide technical assistance to ensure quality and regulatory compliance - Maintain knowledge of industry trends by attending trainings, reading journals, books and other appropriate literature Other duties as assigned

Requirements

- Master of Science Degree and minimum 8 years of experience in Quality Control - Two years’ experience in a leadership role - Familiar with packaging wrapper - Three to five years of laboratory experience performing QC tests and interpreting results within specified guidelines - Strong verbal and written communication skills - Strong interpersonal, organizational, and coaching skills - Strong leadership skills - Ability to think analytically, solve problems and provide resolution to conflicts - Must be detail-oriented - Good understanding of Good Manufacturing Practices - Ability to perform multiple tasks simultaneously with accuracy and precision - Ability to be self-motivated, energetic, enthusiastic and team oriented

Employment Type

  • Full Time

Seniority

Details

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