Compliance Specialist I

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.