Compliance Specialist I

Boston Analytical • Salem, NH

8d

About The Position

The Compliance Specialist I oversees internal and external auditing programs and supports the company’s document control and training programs. The role includes preparing for and hosting client and regulatory audits and inspections, coordinating audit activities, and managing audit follow-up. The specialist also leads investigations for audits conducted by BA Sciences, including internal and supplier audits.

The position supports quality systems through supplier auditing, review and processing of internally created documents, maintenance and archiving of quality files, upkeep of procedures and policies, and tracking documents on site and off site.

Requirements

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

Nice To Haves

• Enthusiastic team player who collaborates across departments to achieve common goals.
• Ability to focus on internal processes while maintaining focus on client needs.

Responsibilities

• Oversee the internal audit program for GMP and ISO compliance.
• Generate 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.
• Schedule and host client and regulatory audits and inspections.
• Perform audit preparation activities.
• Author audit responses and coordinate associated activities.
• Lead the supplier auditing program.
• Schedule supplier audit activities in alignment with supplier qualification program requirements.
• Work with QA Management to determine acceptance of supplier audit responses and questionnaires.
• Perform routine supplier reviews.
• Assist in processing internally created documents, including Methods, Standard Operating Procedures (SOPs), and correspondence.
• Assist with maintaining and efficiently archiving Quality files.
• Maintain procedures and policies associated with quality systems.
• Track documents on site and off site.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level