Lead, QA/QC

Duties And Responsibilities

• Maintain and use quality systems, including but not limited to, change control, deviation management, corrective and preventive action (CAPA) programs, etc.
• Maintain document management systems for creation, approval, maintenance, issuance, control, and storage of GxP documents.
• Aids in establishing and delivering training programs and continuing education programs in the areas of quality assurance with emphasis on ensuring that the employee base has a clear understanding of regulatory quality system processes and tools including GxP requirements.
• Assist other departments in defining training requirements and liaise to ensure successful implementation.
• Liaise with and provide quality oversight to contract manufacturing organizations (CMOs) and contract laboratory organizations (CLOs) including review of respective change controls, deviations, CAPAs, etc. with potential impact to product.
• Manage internal and third party investigation and deviation meetings and establish disposition metrics for USWM and third parties.
• Communicate product quality issues to management and provide information during Quality/Material Review board meetings when out of specification results, investigations, or other issues impact batch disposition or the status of marketed batches.
• Provide QA/QC guidance to and support for development, clinical, and technology transfer projects.
• Manage stability program management for development, clinical, and commercial products and quality oversight of CLOs.
• Compile and review stability reports and perform stability data trending.
• Support vendor management and qualification program activities which may include but is not limited to external auditing - scheduling; planning; auditing; reporting; and follow ups with vendor through CAPA closure.
• Maintain and revise Quality/Technical Agreements and monitor adherence to terms.
• Support the internal audit schedule, performing internal audits of other GXP departments, and ensuring follow ups are complete.
• Support regulatory inspections / being part of team that supports inspections, responds to findings, and completes/oversees follow up actions.
• Support Complaint/Adverse Event programs.
• Provide timely investigation resolution of complaints and adverse events.
• Support the recall program and participating in annual mock recalls to ensure recall preparedness.
• Support the regulatory department including compilation of data for clinical or commercial products to support annual reports or submission updates.

Qualifications

• Bachelor’s Degree in Science or Engineering discipline
• Minimum 5 years work experience in the pharmaceutical, medical device or biologics industry
• Strong team contributor
• Experience with cGxP quality systems
• Cross-functional experience with technical background in analytical, quality control or process development is preferred
• Data analysis, trending and interpretation skills needed
• Experience with biologics, devices, combination products and/or small molecules, multiple dosage forms and routes of administration desired