QA Specialist
Location:
Westborough , Massachusetts
Posted:
December 14, 2017
Reference:
2998768
About Us:

GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer at http://www.ge.com/sites/default/files/15-000845%20EEO%20combined.pdf . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Role Summary:

This position involves working within the QA department to facilitate the carrying out of QA activities, which include the review of key documentation to support product release.

Essential Responsibilities:

• Reviewing of production documentation and assisting with batch release procedures

• Liaising with Operations personnel to ensure regulatory and quality requirements are met during routine operations

• Supporting the ongoing deviation / corrective action program

• Liaising with other departments to allow closure of corrective actions

• Participating in audits, together with follow up.

• Responding to routine quality related queries from other departments

• Monitoring and aiding the implementation of continuous improvements and process changes to ensure that these are implemented in compliance with GMP. • training of Operations personnel

• Attending a number of cross functional team meetings / projects

• Support the timely release of product to market.

• Conducting QA activities including revision of SOPs, SAP QA work and the issuance of protocols.

• Review, Approval and Reporting Activities related to the QMS

Quality Specific Goals:

1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position

2. Complete all planned Quality & Compliance training within the defined deadlines

3. Identify and report any quality or compliance concerns and take immediate corrective action as required

4. Zero repeat findings from previous internal and external audits within area of responsibility.

5. 100% on time CAPA closure for corrective action investigations

Qualifications/Requirements:

1. B.S. Degree in business or technical field or equivalent experience

2. 1-year experience in a medical device or pharmaceutical industry.

3. 1-year experience with CA/PA systems, including complaint handling.

4. Thorough familiarity with cGMPs of sterile product manufacture

5. Knowledge of relevant Electronic Management Systems transactions and familiarity with Excel / Word packages

Desired Characteristics:

1. Statistics education and or training

2. Experience developing and tracking quality metrics

3. Familiar with Continuous Improvement methodologies, including Six Sigma

Locations: United States; Massachusetts; Westborough

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer at http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditional upon the successful completion​ of a background investigation and drug screen.

A little about us:
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