As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer!
This position is part of the Clinical Diagnostics Division (CDD) which provides innovative diagnostic solutions for select IVD market segments and has been a trusted supplier in the IVD industry for over 40 years. CDD delivers products for drugs of abuse testing, therapeutic drug monitoring, quality control, sepsis diagnosis, prenatal screening, advanced laboratory instrumentation and high-throughput laboratory automation equipment for use in a variety of laboratory settings.
The Staff Quality Assurance Engineer is responsible for driving project GMP Quality Engineering activities across multiple sites including the support of technical transfers, site to site transfers, or secondary material qualifications. This position assists in overall GMP transfer and validation strategy development, can provide guidance on compliance related questions within the production environment across multiple production sites. Also performs internal quality audits and performs contract manufacturer and vendor audits, as needed.
How you will make an impact:
Serve as divisional quality engineer including participating as the regulatory compliance SME in determining activities that can be performed at individual sites and feasibility of new business initiatives, development of risk assessments, FMEAs, and other risk mitigation initiatives.
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 properly used. Responsible for oversight of the quality review of operational paperwork, creation of device 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.
Lead Continuous Improvement Activities: Drive functional strategy, the creation, update and consolidation of SOPs, change control and collection of data or measurement of critical compliance related performance indicators as part of the continuous improvement plan.
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 driven 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 to US FDA 21 CFR 820.
Serve as QA representative for IT initiatives, DI projects, and periodic audit trail and US FDA 21 CFR 820 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 in Scientific/Technical field (i.e. Chemistry, Biology, Biotechnology or Engineering) or combination of education and experience.
Master's Degree preferred.
Requires 5+ years of supervisory experience in a GMP or similarly regulated facility.
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 literacy, 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 managed
Requires excellent interpersonal skills, planning/organization skills, strategy and customer focus.
Requires ability to balance multiple tasks while ensuring timely and accurate completion.
CERTIFICATES AND/ OR LICENSES:
Certified Quality Auditor – ASQ preferred
Other certifications related to services provided are advantageous (i.e. CTBS, CQE, etc.)
