- 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