Compliance Specialist

Proclinical is currently recruiting for a Compliance Specialist with a pharmaceutical company located in Boston, MA.

Job Responsibilities:

• Responsible for generating, reviewing, providing assessments and maintaining out of specification (OOS) reports, deviation reports, CAPAs and Change Control for Analytical Sciences.
• Provide key assistance in QA audits and design correction action to observations
• Maintain the training matrix of GAPD
• Conducts reviews of new procedures and proposed changes to current procedures for compliance with regulatory and corporate requirements; presents findings
• Identifies opportunities for improvement in systems and makes recommendations for effective changes to ensure compliance with cGMP
• Oversee equipment maintenance including maintaining PM calendar, schedule calibration and services, review, approve and maintain equipment binders and log books
• Maintain Inventory of reference standards, critical samples and reagents. Coordinate qualification of reference standards and prepare qualification reports.
• Create timelines and plans to meet established targets; goals and objectives

Skills and Requirements:

• Bachelor's Degree or higher
• Experience with quality improvement projects
• Experience with Trackwise or equivalent quality system for change control, deviation, CAPA, Lab Investigation
• Experience with Veeva Vault EDMS or equivalent

If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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