Compliance Specialist I
Boston Analytical
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- Location
- Salem, NH
- Job type
- Full time
- Posted
- Oct 30
- 1 day ago
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Career path
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What you'll do
- Generate the internal audit schedule and coordinate audit activities
- Track audit activities and follow-up requirements
- Schedule and host client and regulatory audits/inspections
- Author audit responses and coordinate associated activities
- Lead the supplier auditing program and perform routine supplier reviews
- Assist in processing internally created documents
- Maintain and archive Quality files and track documents
What you need
- Bachelor’s degree in a related discipline
- 2+ years with a combination of QA/QC and auditing experience in the pharmaceutical industry
- Strong familiarity with cGMP and GLP regulatory/compliance environments
- Experience in root cause analysis, risk management, and corrective/preventative action development
- Enthusiastic team player, collaborative across all departments (preferred)
- Ability to focus on internal processes while maintaining focus on client needs (preferred)
Key skills
GMPISO complianceAuditingcGMPGLPRoot cause analysisRisk managementCorrective/preventative action
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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.