Compliance Specialist.

Title: Compliance Specialist
Duration: 12+ months
Location: New Haven, CT
 
POSITION SUMMARY

Analytical Sciences Compliance Specialist (or Process Development Associate) is responsible for maintaining quality compliance in Analytical Sciences laboratories by identifying quality requirements, disseminating policies, procedures, conducting audits, recommending improvement plans and performing compliance tasks. Additionally, this candidate will be responsible for all equipment maintenance including maintaining calibration schedules and approving equipment qualification packages.  
 
Principal 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 logbooks  
• 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.

Qualifications:

• 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  
• Experience with procedure creations or revisions  
• Experience with maintenance of training curriculum and/or training files 

Education:

A successful candidate will typically hold a bachelor’s degree in the science field.