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Added 11 days ago
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Boston Analytical

Compliance Specialist I

Salem, NH, United States

Apply on bostonanalytical.bamboohr.com About employer

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Job details

Experience: Qualifications include a bachelor’s degree in a related discipline with 2+ years with a combination of QA/QC and auditing experience in the pharmaceutical industry.
Posting language: English
Posted: Oct 30, 2026

Original job description

JOB SUMMARY

The Compliance Specialist has oversight responsibilities for the internal and external auditing programs, for supporting the maintenance of the company’s document control and training programs. This includes hosting audits from clients and regulators, including audit preparation and follow-up activities. The Compliance Specialist also acts as lead investigator for audits conducted by BA Sciences (e.g. internal and supplier audits).

PRIMARY DUTIES AND RESPONISIBILITIES

Oversight of the internal audit program for both GMP and ISO compliance
Generation of the internal audit schedule
Coordinate audit activities with applicable departments
Track audit activities and follow-up requirements
Work with QA Management to determine acceptance of audit responses
Scheduling and hosting of client and regulatory audits/inspections
Audit preparation activities
Hosting of audits
Author audit responses and coordinating associated activities
Lead supplier auditing program
Schedule audit activities to align with supplier qualification program requirements
Work with QA Management to determine acceptance of audit responses and questionnaires
Perform routine review of suppliers
Assist in processing internally created documents such as Methods, Standard Operating Procedures (SOPs) and correspondences.
Assist in the maintenance and archive the Quality files in an efficient manner.
Maintain all procedures and policies associated with these quality systems.
Track documents on site and off site

REQUIREMENTS & QUALIFICATIONS

Qualifications include a bachelor’s degree in a related discipline with 2+ years with a combination of QA/QC and auditing experience in the pharmaceutical industry.

Strong familiarity with regulatory/compliance environment (cGMP, GLP) associated with biotechnological, parenteral drug manufacture and/or medical device production.

Experience in root cause analysis, risk management, and corrective/preventative action development.

DESIRED SKILLS

Enthusiastic team player, collaborative across all departments to achieve the common goals.

Ability to focus on internal processes while maintaining focus on client needs.

Apply on bostonanalytical.bamboohr.com About employer

More about this job

Skills

Regulatory compliance
Auditing
Good manufacturing practices
Scheduling
Inspection
Quality control systems
Pharmaceutical industry
Good laboratory practices
Root cause analysis
Risk management

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