Job Description
Job Description
Position: Quality Compliance Lead
Location: Vermont
We are seeking a Quality Compliance Lead to oversee internal compliance audits and ensure adherence to global quality standards. This role is critical for maintaining inspection readiness and driving continuous improvement across site operations.
Key Responsibilities:
- Develop and manage the site self-inspection program, including schedules and agendas.
- Conduct planned and unplanned inspections; document and communicate findings.
- Track and verify CAPAs for effectiveness; provide guidance to ensure robust corrective actions.
- Prepare trend reports and share insights to identify improvement opportunities.
- Support audit readiness and participate in regulatory and internal audits.
- Perform external audits of suppliers as required.
- Deliver training and coaching to site teams on audit processes and compliance.
Qualifications:
- Bachelor's degree in Science, Engineering, or related field.
- 10+ years in a GxP environment with strong knowledge of cGMP and global regulations (FDA, EMA, ICH, ISO).
- Expertise in quality systems and compliance auditing.
- Must be authorized to work in the US without Visa Sponsorship
Company DescriptionA top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.
Job Responsibilities:
•\tConducting Post Market Activities and Post Market Surveillance
•\tManaging Customer and Product Complaint Investigation programs
Education and Experience:
•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry
•\tBachelor's degree
•\tComputer proficiency
Company Description
A top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.\r\nJob Responsibilities:\r\n•\tConducting Post Market Activities and Post Market Surveillance\r\n•\tManaging Customer and Product Complaint Investigation programs\r\nEducation and Experience:\r\n•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry\r\n•\tBachelor's degree\r\n•\tComputer proficiency