GMP/ISO Compliance Auditor I

Boston Analytical; Salem (NH); On-site; USD 65,000 - 90,000; Full time

Job summary

Boston Analytical is seeking a Compliance Specialist to oversee internal and external auditing programs, support document control and training initiatives, and host audits from clients and regulators. The role includes leading audits by BA Sciences and coordinating audit responses with QA Management.

Qualifications include a bachelor’s degree with 2+ years QA/QC/auditing in pharma, strong regulatory knowledge (cGMP, GLP), and experience with root cause analysis and CAPA development.

Qualifications

• Bachelor’s degree in a related discipline with 2+ years QA/QC and auditing experience in the pharmaceutical industry.
• Strong familiarity with regulatory/compliance environment (cGMP, GLP) in biotechnological, parenteral drug manufacture and/or medical device production.
• Experience in root cause analysis, risk management, and corrective/preventive action development.

Responsibilities

• Oversight of the internal audit program for GMP and ISO compliance.
• Generation of the internal audit schedule and coordination with departments.
• Track audit activities and follow-up requirements.
• Host client and regulatory audits/inspections and prepare responses.
• Lead supplier auditing program and align with supplier qualification.
• Assist in processing documents such as SOPs and QA correspondence.
• Maintain quality files and track documents on and off site.
• Work with QA Management to determine acceptance of audit responses.

Skills

Audit management

Regulatory compliance

Root cause analysis

Documentation control

Team collaboration

Education

Bachelor's degree in related discipline

Tools

Document control systems

Job description

Boston Analytical is seeking a Compliance Specialist to oversee internal and external auditing programs, support document control and training initiatives, and host audits from clients and regulators. The role includes leading audits by BA Sciences and coordinating audit responses with QA Management.

Qualifications include a bachelor’s degree with 2+ years QA/QC/auditing in pharma, strong regulatory knowledge (cGMP, GLP), and experience with root cause analysis and CAPA development.