Quality Assurance Specialist II

at  Thermo Fisher Scientific

JOB DESCRIPTION

The Quality Assurance team is responsible for reviewing equipment validations, process validations, change control requests, technical transfers, supplier changes, and new product initiatives for RUO and IVD TDX HLA Typing kits and reagents.
Validation work includes the ability to perform risk assessments to identify the extent of validation required.
The QA Specialist II position requires the ability to write/review protocols and write/review reports for validation and new design processes. The application of risk assessment methodology is required for this position in order to support a fast-paced Change Control system while maintaining all IVD Compliance Requirements, where applicable.
Technical Transfer activities include reviewing protocols and reports along with collaboration during the design control process in order to develop robust manufacturing processes, QC methods, and documentation to support the DMR. The QA Specialist II may sit on Core Teams or assist the Core Team in developing processes and transferring knowledge between different teams. This position is constantly cross functional in nature and requires independent thought and schedule adherence, under moderate levels of guidance.
This position will also take care of supplier management, ensuring the best possible interaction between the business and critical suppliers.
Key Responsibilities:
 Review validation projects, protocols, and reports in support of equipment and process validation.
 Write and review protocols and reports.
 Assist in Risk Assessment exercises
 Collaborate with R&D, Product Development Manager, Technical Operations, and Operations to ensure successful process development and technical transfers.
 Coordinate validation activities/reviews in support of assigned validation projects working closely with Subject Matter Authorities.
 Recommend approval or failure of validation studies.
 Maintain knowledge and comprehensive understanding of relevant Medical Device regulations and
current interpretations affecting equipment, product and process validation.
 Maintain Supplier Quality program; evaluate suppliers, issue Supplier Corrective Actions, assist with Supplier audits, process and assess supplier changes.
 Act as a resource to other departments for product and process knowledge.
 Able to work independently.
 Ability to learn new products and technology.
 Able to effectively lead a project involving a peer group.
 Lead and/or participate in product related team meetings and/or performance reviews, as needed.
 Assist with QA department functions as needed.
 Perform computer operations for data entry and provide tracing/trending reports.
 Additional support of routine QA department standard operating procedures (SOPs) is also expected when vital.
Minimum Requirements:
 Bachelor’s degree in Biology, Chemistry, or other similar Life Science field.
 3+ years proven experience in Quality regulated environment
 Detailed knowledge of ISO and GMP regulations which govern a medical device and diagnostics
manufacturing
 Able to create presentations, work with spreadsheets, prepare reports and write procedures applying MS Word, Excel and PowerPoint software applications.
 Consistently demonstrated validation proficiency, with knowledge of equipment qualification
(IQ/OQ/PQ), process validation, and computer/automation systems.
 Good analytical skills, with an ability to use scientific knowledge and statistical methods to identify
root causes of process and product failures.
 Strong project management and organizational skills.
 Proven technical skills in process validation & concepts with an emphasis on
implementation.
 Excellent verbal and written communication skills.
 Previous experience in problem solving methodology.

Please refer the Job description for details