Compliance Specialist 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

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.