Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Job Description

Joining Thermo Fisher Scientific and make a positive impact on a global scale. We collaborate to fulfill our Mission of improving health, the environment, and safety. The teams have the resources to achieve personal career objectives and address important challenges in areas like environmental protection, food safety, and cancer research.

The Clinical Diagnostics Division (CDD) offers diagnostic solutions for specific IVD market segments. They have been a reliable supplier in the IVD industry for over 40 years. CDD provides products for drugs of abuse testing, therapeutic drug monitoring, quality control, sepsis diagnosis, prenatal screening, laboratory instrumentation, and laboratory automation equipment.

Responsible for GMP Quality Engineering activities, the Senior Quality Engineer coordinates technical transfers, site to site transfers, and secondary material qualifications across multiple sites. They assist in developing strategies for GMP transfer and validation and provide support in the production environment. The role also includes conducting internal quality audits and audits of contract manufacturers and vendors.

How you will make an impact:

Participate as the regulatory compliance SME in selecting activities that can be performed at individual sites and assessing the feasibility of new business initiatives. Develop risk assessments, FMEAs, and other risk mitigation initiatives as the divisional quality engineer.Serve as Quality SME to ensure ongoing facility compliance to FDA 21 CFR 11, 58, 210, 211, 600-680, 820, 1271, EU cGMPs, DEA controlled substance regulations, state pharmacy regulations, TGA regulations, PMDA regulations, and NABP/VAWD requirements and perform regular gap assessments of each site to increase licensing and operational capabilities.Ensure quality documents, protocols, methods, material records are current, accurate and accurately employed. Responsible for oversight of the quality review of operational paperwork, creation of master records, client label specifications, validation protocols, and provide QA/QC metrics to detect any recurring quality issues, reviewing and approving project-related change controls.Drive functional strategy for continuous improvement by leading activities such as updating SOPs, implementing change control, and collecting data on compliance performance indicators.Coordinate with colleagues within CDD to drive global standardization efforts, serving as liaison between business unit and divisional and group counterparts.Develop training requirements, matrices, and OTJ requirements for division validations, technical transfers, and material qualifications projects.

Support Software compliance - develop and review User/Functional requirements, review & approve test scripts, review validation plans; ensure compliance.

Serve as QA representative for IT initiatives, DI projects, and periodic audit trail compliance reviews, as needed.Support and lead internal audits, supplier audits and client audit processes, as needed.Author and/or review device master records (DMRs), Standard Work Instructions (SWI), Client Work Instructions (CWI), Material Specifications, Standard Operation Procedures (SOP), and Validation Protocols, as needed.

Education/ experience:

Requires Bachelor's Degree, equivalent experience in a Scientific/Technical field (i.e. Chemistry, Biology, Biotechnology or Engineering).Master’s Degree preferred.Requires 5+ years cGMP hands-on experience in Quality.

Knowledge skills and abilities:

Knowledge of global medical device, and biologic GMP regulations and their appropriate application to ensure compliance of facilities including knowledge of software compliance (21 CFR Part 11)Proficient with personal digital knowledge, specifically Microsoft office applications, with the ability to learn new computer systems quickly.Requires adept in attention to detail/follow up and problem-solving skills in situations that are not procedurally ledRequires excellent social proficiency, planning/organization skills, strategy and customer interface.Requires ability to balance multiple tasks while ensuring timely and accurate completion.

Certificates and/ or licenses:Certified Quality Auditor – ASQ preferredOther certifications related to services provided are useful (i.e. CTBS, CQE, etc.)

Travel:Travel requirements of 50-75%, based on project needs

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.