Compliance Specialist I

BA Sciences

. Oversee internal audit programs for GMP and ISO compliance .

Posted 10/30/2026full-timeSalem • New Hampshire • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in overseeing internal audit programs for GMP and ISO compliance, with a strong focus on regulatory requirements in the pharmaceutical industry. Proficient in root cause analysis, risk management, and corrective/preventative action development while maintaining collaboration across departments.

Highest-signal resume keywords

GMP ComplianceISO ComplianceAuditing ExperienceRoot Cause AnalysisRisk Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Internal Audit ProgramsAudit SchedulingAudit PreparationSupplier AuditingQuality Systems Maintenance

Soft Skills

CollaborationClient Focus

Tools & Technologies

Standard Operating Procedures (SOPs)Quality Files Management

Industry Keywords

Pharmaceutical IndustryCGMPGLPBiotechnological ManufacturingMedical Device Production

About the role

Key responsibilities & impact

Oversee internal audit programs for GMP and ISO compliance
Generate internal audit schedules
Coordinate audit activities with applicable departments
Track audit activities and follow-up requirements
Work with QA Management to determine acceptance of audit responses
Schedule and host client and regulatory audits/inspections
Perform audit preparation and follow-up activities
Author audit responses and coordinate associated activities
Lead the supplier auditing program
Schedule supplier audits to align with supplier qualification requirements
Perform routine supplier reviews
Assist with processing internally created documents, including Methods, Standard Operating Procedures (SOPs), and correspondence
Maintain and archive Quality files
Maintain procedures and policies associated with quality systems
Track documents on site and off site

Requirements

What you’ll need

Bachelor's degree in a related discipline
2+ years of combined QA/QC and auditing experience in the pharmaceutical industry
Strong familiarity with the regulatory/compliance environment, including cGMP and GLP, associated with biotechnological, parenteral drug manufacture and/or medical device production
Experience in root cause analysis, risk management, and corrective/preventative action development
Ability to collaborate across all departments
Ability to focus on internal processes while maintaining focus on client needs