Senior Compliance Auditor - Cambridge, United States - EPM Scientific

Description

Job Description

Job Description

Senior Compliance Auditor

Role Description:

• Oversee and participate in audits, reporting on findings.
• Manage Quality Technical Agreements with critical suppliers.
• Conduct internal audits to meet GMPs, 820 standards, and company requirements.
• Lead and support supplier audits (onsite and remote) for GMP and regulatory compliance.
• Uphold the Supplier Management Program, including drafting and maintaining Quality Technical Agreements.
• Address and escalate compliance issues to the appropriate teams.
• Support the Supplier Management Team and medical device supplier project teams.
• Develop and revise Standard Operating Procedures (SOPs).

Role Requirements:

• Bachelor's degree or equivalent with 10 years of experience in a pharmaceutical/biotech quality unit.
• 5+ years of experience as a qualified auditor, assessing supplier compliance with cGMP, QSR, and ICH regulations.
• Strong understanding of relevant FDA regulations/guidance and ICH Guidelines.
• Proven ability to independently plan, execute, and report audits.
• Experience in cell manufacturing/biologics, medical devices, and/or software quality is a plus.
• Familiarity with Good Clinical Practice (GCP) and ICH E6 is preferred.

This role is hybrid (Mon, Tue, Thu onsite) with 30% travel within Massachusetts and Michigan.

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
Job Responsibilities:\r

•\tConducting Post Market Activities and Post Market Surveillance\r

•\tManaging Customer and Product Complaint Investigation programs\r
Education and Experience:\r

•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry\r

•\tBachelor's degree\r

•\tComputer proficiency