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