RESPONSIBILITIES:
• Assist in supervision of various quality programs such as but limited to labeling, GMP training, compliance, document control, information tracking, and equipment calibration.
• Manages or assists in the compliance profile of the site and drives continuous improvements, QRB and metrics.
• Review and approve protocol/reports for various qualifications and validations.
• Uses statistical process control to evaluate trends. Provide periodic KPI trend reports to senior management as required.
• Review and approve Manufacturing, Packaging, and Quality Operation Processes, and GMP documentation.
• Approve Master Labels and Finished Product C of A's. Assist with creation, revision and approval of SOP's. Review and approve change controls.
• Improves and/or develops comprehensive quality sub-systems (e.g., corrective/preventative action, MRB, customer complaints, vendor management programs, etc.).
• Assist Senior Management during inspections by FDA, DEA, and other regulatory agencies and customers.
• Helps in establishing raw material and finished product specifications based on regulatory requirements and customer needs.
• Lead investigation activities, perform root-cause analyses, and develop corrective and preventative action plans.
• Assist in preparations for Annual Product Review.
• Comply with cGMP regulations and follow all standard operating procedures.
• Other related duties as required.
QUALIFICATIONS:
• Bachelor's Degree, preferable in a scientific discipline.
• 6+ years of experience in Quality Assurance in a GMP facility, including people management and/or equivalent combination of education and experience.
• Strong commitment to quality standards with leadership and management skills.
• Ability to read and interpret technical procedures, SOP's, GMP's and governmental regulations: 21 CFR 111, 11, 210, and 211.
• Strong communication skills, both written and verbal.
• Possess positive qualities of effective leadership, staff motivation and conflict resolution.
• ASQC quality certifications, ISO 9000 or other Audit training preferred.
• Strong knowledge of validation, investigations, application of audit principles, concepts and practices related to a regulated quality system is required.
• Strong solid dose manufacturing quality compliance experience is preferred.
We offer medical, dental, vision and company matching 401K.
