Compliance Specialist job in Boston, USA

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First Name*

Last Name*

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Phone Number*

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First Name*

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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP)

Location: United States

This vacancy has now expired. Please see similar roles below...

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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