Quality Assurance Associate

Position Overview

The person in this position will be responsible for supporting QA Systems in conjunction with the Quality Assurance Manager.

Responsibilities

• Provides direction on the execution of quality processes for ACT facility employees, providing guidance and expectations on how those systems are to be followed.
• Helps manage the critical document control system. Ensures all facility documents are revised, made effective, and archived in a controlled manner according to appropriate governing policies.
• Tracks QA System progress either through internal auditing or the use of metrics.
• Directs others who are executing validation work, reviews executed work, ensures work is completed against plan.
• Reviews executed batch records, identifies corrections, and helps resolve issues.
• Investigates occurrences and deviations, identifies potential corrective and preventive actions to improve processes.
• Supports the use of electronic quality management system.
• Aids in the process of creating batch records and forms needed to support the process.
• Completes initial review of batch records. Initiates and investigates deviations related to the manufacturing and release of products.
• Tracks and trends manufacturing errors and other metrics for KPIs.
• Supports material release, inspects incoming materials, ensures they meet specifications for use within manufacturing.
• Technical writer and resource for policies, Standard Operating Procedures, forms, worksheets, and job aids in support of quality and manufacturing operations.
• Aids and supports manufacturing in identifying needed policies, Standard Operating Procedures, and other required documents.
• Be a liaison for manufacturing to support projects.
• Maintain annual competencies in required quality functions and remain up to date in required EHS LMS modules.
• Assist in training other QA / QC members in ACT Quality Systems.
• Aid in the maintenance of quality electronic systems.
• Participate in 5 hours of continuing education annually in cellular therapy or quality topics.

Skills

• Experience with MasterControl is beneficial.

Pay

If hired, the pay rate is $33.65 / Hour.

Benefits

• 401k Retirement Savings Plan administered by Merrill Lynch
• Commuter Check Pretax Commuter Benefits
• Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO

Contact

If interested, you may contact: Carlo Flores
Carlo.Flores@eclaro.com
646-695-2934

ECLARO Benefits

• Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.