QA Specialist II

MAIN PURPOSE OF ROLE
This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.

MAIN RESPONSIBILITIES
Assist with administration and ensuring compliance to Quality Management Systems including:
Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
Lead the investigation, resolution and prevention of product and process nonconformances
Actively monitors Third Party Manufacturers data and Support areas for compliance with internal Standard Operating Procedures (SOPs) and relevant regulatory (cGMP, ISO) regulations.
Reviews GMP related documentation for compliance such as batch records and associated data related to product manufacturing, testing and release, validation protocols and reports, labels, product specifications and other documentation as required.
Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations in the Manufacturing area as required.
Lead the investigation, resolution and prevention of product and process nonconformances
Writes and revises SOPs, controlled forms, and related documents to ensure best practices and alignment with current operations.
Collaborates with members of the Quality Assurance team working on special projects.
Participate on permanent and temporary teams which are process or project driven.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Collect, analyze, and publish quality metrics.
Assist with other support duties as assigned.

QUALIFICATIONS

Education
Bachelors Degree in an Engineering or Technical Field, or an equivalent combination of education and work experience.

Experience/Background