Quality Specialist II

at  Thermo Fisher Scientific

JOB DESCRIPTION

Position Summary
The Quality Assurance team is responsible for reviewing equipment validations, process validations, change control, technical transfers, 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 cross functional 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.

Key Responsibilities:

• Review validation projects, protocols, and reports in support of equipment and process validation.
• Write and review protocols and reports.
• Review IQ/OQ protocols and reports.
• Assist in Risk Assessment exercises in support of validation activities.
• 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 Subject Matter Experts.
• 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.
• Act as a resource to other departments for product and process knowledge.
• Able to work independently, with guidance from the Quality Assurance team.
• Ability to learn new products and technology.
• Able to successfully 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. (Specific duties may vary and will be documented in department records, job assignments and/or project action items).
• 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 necessary.
• Exhibits a high level of quality (right the first time), integrity (do what you say you are going to do), and cross functional behavior (always stay above the line).
• Embody the Thermo Fisher 4-I Values at all times

Minimum Requirements:

• Bachelor’s degree in Biology, Chemistry, or other similar Life Science field.
• 3-5 years relevant 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 utilizing 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.
• Demonstrated technical skills in process validation & concepts with an emphasis on implementation.
• Excellent verbal and written communication skills.
• Previous experience in problem solving methodology.
• Possess a continuous process improvement mindset with the ability to effectively lead and manage change.
• Performs all job duties in a safe manner, consistent with the Code of Ethics and the Thermo Fisher Scientific 4-I core values of Integrity, Intensity, Innovation, and Involvement.
• Performs other duties as assigned

• Review validation projects, protocols, and reports in support of equipment and process validation.
• Write and review protocols and reports.
• Review IQ/OQ protocols and reports.
• Assist in Risk Assessment exercises in support of validation activities.
• 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 Subject Matter Experts.
• 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.
• Act as a resource to other departments for product and process knowledge.
• Able to work independently, with guidance from the Quality Assurance team.
• Ability to learn new products and technology.
• Able to successfully 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. (Specific duties may vary and will be documented in department records, job assignments and/or project action items).
• 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 necessary.
• Exhibits a high level of quality (right the first time), integrity (do what you say you are going to do), and cross functional behavior (always stay above the line).
• Embody the Thermo Fisher 4-I Values at all time