Compliance Specialist
- Permanent
- Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP)
- United States
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.
#LI-BC1
Related jobs
Highly Competitive Salary
Boston, USA
Proclinical is currently recruiting for an Associate Director of GMP/GDP Audit and Inspection Management for a leading biopharmaceutical company located in Boston, MA.
Highly Competitive Salary
New York, USA
Proclinical is currently recruiting for an Associate Director of GCP Audit Management for a leading pharmaceutical company located remotely in the east coast.
Highly Competitive Salary
North Chicago, USA
Proclinical is currently recruiting for a Product Compliant Analyst with a biopharmaceutical company located in North Chicago, IL.
Highly Competitive
Basel, Switzerland
An exciting opportunity has arisen for a Quality Manager to oversee Technical Research Development in Switzerland.
Highly Competitive
Basel, Switzerland
An exciting vacancy has arisen for a Quality Expert, working Medical Device Software
Highly Competitive Salary
Raritan, USA
Proclinical is currently recruiting for a QA Investigations Lead with a pharmaceutical company located in Raritan, NJ.
Highly Competitive Salary
Philadelphia, USA
Proclinical is currently recruiting for a Quality Labeling Specialist with a pharmaceutical company located in Philadelphia, PA.
Highly Competitive Salary
Wilmington, USA
Proclinical is currently recruiting for a Quality Labeling Specialist with a pharmaceutical company located in Wilmington, DE.
Highly Competitive Salary
Raritan, USA
Proclinical is currently recruiting for a Quality Engineer (QA Risk Management Specialist) for a multinational biopharmaceutical company located in Raritan, NJ.
Highly Competitive Salary
Raritan, USA
Proclinical is currently recruiting for a QA Investigations Lead with a pharmaceutical company located in Raritan, NJ.