Job Description
Job Description
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.
At LGM Pharma, we always take pride in putting our people first. We are an equal opportunity employer. We offer medical, dental, vision and company matching 401K. All suitably qualified candidates will receive consideration for employment based on objective work-related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws.