Qa Investigations Lead

Qa Investigations Lead
Company:

Zachary Piper Solutions, Llc


Qa Investigations Lead

Details of the offer

Piper Companies is seeking a QA Investigation Lead in
Raritan, NJ
to join a Quality Operations team supporting CAR-T manufacturing and overall advancement of the investigational treatment.
The QA Investigations Lead will provide quality oversight over production of personalized cell therapy to support clinical and commercial requirements in a sterile GMP environment. This includes supporting and approving manufacturing investigations, ownership of various department projects, and tracking of quality metrics while ensuring high quality and complaint product supply.
Responsibilities of the
QA Investigations Lead
include:
Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs
Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues
Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints
Review and approve manufacturing procedures
Support regulatory inspections and audits by ensuring inspection readiness within facility
Perform internal housekeeping audits
Perform analysis on quality indicating data and identifying trends.
Provide oversight for trending of quality compliance metrics
Qualificatoins for the
QA Investigations Lead
include:
• B.S. in Science, Engineering or related field
• 4+ years' experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices
• Must be able to summarize and present results, and experience with team-based collaborations
• Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk
• Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality
• Must be able to discern the criticality of issues and to communicate to management regarding complex issues
• Ability to manage conflict and issues that arise with internal or external customers
Compensation for the
QA Investigations Lead
include:
$80,000-$100,000 salary, 10% annual bonus, Exempt Employee
10 Paid Holidays plus an additional 3 Floating Holidays
3 weeks' Vacation Days; 5 additional Personal Days; Up to 5 Sick Days

Requirements

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