• Reviews document change requests, document change controls, investigations, non-conformances, work orders/BOM, protocols, reports, batch records, and other GMP documents in a timely manner.
• Leads the CAPA review board, the CAPA process and makes recommendations for corrective actions
• Assure compliance with regulatory requirements and internal company procedures by planning, conducting, reporting quality inspections; internal and external facility evaluations, system audits, and data reviews that support company product releases.
• Draft, review, revise, approve, and authorize procedures, work instructions, protocols, validations, specifications, and qualifications
• Track and trend planned and unplanned deviations, complaints, and corrective actions
• Reviews and approves ingredients/materials for use in commercial production.
• Assist management in federal, state, local and external registrar audits/inspections.
• Assists in development of QA statistical analysis/reports and plans, and documentation
• Performs statistical analysis for non-conformities
• Perform trending analysis related to quality systems and generate associated reports for quality and site management as required
• Assists in the development and implementation of design of experiments and serves on problem solving teams.
• Drive continuous improvement of site quality systems. Performs gap assessments with quality systems and drug/device master files ensure compliance
• Coordinate and perform the drafting of Quality Agreements with suppliers of materials/services and with customers. Will also ensure commitments within approved quality agreements are met.
• Participate on cross-functional teams to facilitate new product launches in domestic and international markets.
• Other duties as assigned.

Key Requirements

• Experience in handling CAPA, Non-conforming material and Change controls
• Knowledge of regulatory standards, including but not limited to 21 CFR 820; 21 CFR 210/211; ISO 13485, ISO 14971, CMDR, MDD and JPAL.
• Exposure regulatory agency such as FDA is an added advantage

Regularly interfaces with:
Entire Earth City Staff; YI Staff, External Licensing Vendors; Federal, State and Other Government Compliance Officials


Qualifications

• Bachelor’s Degree in life science, engineering or related field
• 3-5 years Quality Assurance experience in Medical Device or Pharmaceutical Industry. Experience in Regulatory will be considered.
• Strong attention to detail
• Able to work in a team environment
• Strong communication skills, both written and verbal