Lead, Quality Assurance

Role Summary

The QA Lead is responsible for the oversight of QA activities including batch record review, media disposition, label issuance, archiving and final product packaging and release. The individual must be able to gown into classified manufacturing ISO 7 clean room areas and inspect the final product.

Responsibilities

• Perform, and ensure that the review of batch records and release of intermediates is performed within required timeframes outlined in SOPs.
• Responsible for the packaging and final batch disposition.
• Responsible for inspection of final product within an ISO 7 cleanroom.
• Support day to day operations, including batch record review, label issuance, archiving and verification with supervision oversight and in a timely manner.
• Follow oral and written procedures for review and release of intermediate and final product.
• Support projects as a QA resource.
• Identify deficiencies and work with cross functional departments to remedy them. Communicate and escalate issues with QA team and Management.
• Identify, address, and/or escalate compliance problems and issues and provide recommendations for process improvements within the department.
• Become a Qualified Trainer for QA Operations.
• Review validation and requalification of equipment and validation discrepancy forms.
• Write, conduct periodic review and revise Standard Operating Procedures.
• Provide oversight to QA Specialist I and II and ensure compliance.
• Participate in audits and represent QA as an SME for specified areas.
• Accountable for timely project completions to meet business needs.
• Independently make decisions on minor issues on behalf of junior staff.
• Act as QA Reviewer managing deviations/events, CAPAs and tasks within TrackWise, including root cause analysis.
• Participate in Change Controls as SMEs and action item owners for QA.
• Generate, evaluate, and report quarterly event trending metrics; present metrics for QMR, PPR and Dashboard Reporting.
• Manage and investigate product complaints.
• Participate in risk assessments, root cause analysis, and data interpretation.
• Other duties as assigned.

Qualifications

• Bachelor’s degree plus 4–6 years of industry-relevant experience or Master’s degree plus 2–4 years of industry-relevant experience.
• Strong interpersonal skills and ability to work in a team environment.
• Strong written and verbal communication.
• Strong organization and time management skills.
• Proficient in MS Office.
• Working knowledge of cGMP regulations.

Preferred Qualifications

• Experience in overseeing a team and projects.
• Knowledge of electronic batch records, ERP systems, and Quality Management Systems (TrackWise and Veeva).
• Ability to interpret Quality standards for implementation and review.