Responsibilities
- Oversee the internal batch release process, verifying documentation accuracy and compliance with company standards, including selective review of Certificates of Analysis and test results.
- Coordinate and monitor Corrective and Preventive Actions arising from internal or contract manufacturer quality concerns.
- Deliver training programs on quality systems, complaint handling, and compliance standards across departments.
- Organize and conduct monthly quality review meetings, presenting summaries of performance trends, key issues, and resolution progress.
- Lead the annual product quality review process with input from multiple departments.
- Advise on customer complaint evaluations and facilitate internal coordination for timely resolution and escalation.
- Analyze patterns in customer complaints and adverse events to inform risk mitigation strategies.
- Direct and document investigations into quality incidents, including deviations, contract manufacturing issues, and product recalls.
- Track CAPA effectiveness and ensure timely closure of corrective actions.
- Assist in executing mock and actual product recall procedures, including internal coordination and recordkeeping.
- Act as the primary QA liaison for Operations, Procurement, Research and Development, and Customer Experience teams.
- Support R&D trial runs and pilot batches by aligning quality specifications, materials, and testing protocols.
- Assess non-commercial materials for use in trials or alternative sourcing initiatives.
- Provide ongoing technical and quality support across business units, including compliance with NASC Adverse Event Reporting and internal awareness programs.
Benefits
- 20 days of paid time off annually, excluding public holidays
- Eligibility for company bonus
- Comprehensive medical, vision, and dental coverage
- Short-term and long-term disability insurance
- Life insurance policy
- 401K retirement plan
- Monthly stipend for coffee, bagels, and lunch via Uber
- Monthly internet allowance
Compensation
Eligibility for an annual bonus of up to 10% of base salary
Work Arrangement
Remote (Worldwide)
Team
Collaborates across Operations, Procurement, R&D, and Customer Experience to ensure quality compliance and continuous improvement.
Other
- Eligibility for an annual bonus of up to 10% of base salary
- Equal opportunity employer committed to diversity and inclusion
Not specified
