Location: All cities,NY, USA
Software Quality Assurance Analyst - Rochester, NY
Long term contract - $40/hr to $50/hr
The Software Quality Assurance Analyst will conduct verification and validation activities for the Shop Floor Information Systems and other computer systems for use in the manufacturing and release of Medical Device products (Contact Lenses) on a project bases and/or process basis.
Software Quality Assurance Analyst for Contact Lens manufacturing platform in the Rochester facility.
Must possess excellent written and verbal communication skills and be able to guide others to make sound Quality decisions. The SQA Analyst must be self-directed and must show initiative in identifying and resolving opportunities for improvement, promoting Quality initiatives.
KEY ACTIVITIES / RESPONSIBILITIES
-Review & approval of test scripts and plans in regard to suitability to proceed with validation activities.
-Development of protocols, test scripts and associated support documentation, where appropriate.
-Oversight of and participation in the execution of software related protocols.
-Conduct Root Cause Analysis and participate in debugging activities.
-Responsible for participation in the Corrective Action process in regard to individual validations to ensure follow-up and effective resolution.
-Provide feedback to the validation strategies to improve data integrity, data verification and software change control.
-Responsible for driving toward new state-of-the-art systems and technologies in support of digitization of manufacturing data inputs and outputs.
-Follow local and regional Standard Operating Procedures while carrying out duties.
-Participate fully in all GMP and operational training programs and complete all training records in an accurate manner.
- Other projects as required.
SCOPE OF POSITION
The SQA Analyst will act as a contributor on software or automation projects, conduct verification and validation activities for Shop Floor Information Systems and other computerized systems for use in the manufacturing and release of Medical Devices on a project basis. The SQA Analyst plays a key role in meeting challenges faced within critical projects and manufacturing operations. Functions independently and as part of a team within Rochester Manufacturing Operations. Must be self-directed, be able to identify requirements and establish procedures and specific objectives. Expected to coordinate work activities, providing direction and support to peers and others. Provides leadership by coordinating work activities, administrative tasks, and advising others. Minimal travel as required.
KEY RELATIONSHIPS
This position must be able to liaise between internal business partners across varying functions. These functions include other members of plant quality, manufacturing, IT, engineering, logistics, supply chain, and R&D. This position must be able to interact with external auditors.
QUALIFICATIONS/ TRAINING
Bachelor's degree in science or related field required. Computer Science Degree preferred.
OR
Minimum 10 years of relevant experience in Quality, IT or Engineering.
-Demonstrated ability to execute software validation and change control activities.
-Knowledge of ISO 13485, FDA 21CFR parts 11, 820 requirements in addition to system development and management in medical device industry.
-Computer experience with MS Office Suite and database type software.
-Demonstrated project management and leadership skills.
-Strong written, oral and interpersonal skills.
-Ability to work in team environment.
-Ability to manage varied workload and prioritize effectively.