The Operations Quality Specialist II is a critical member of the Operations Team. The Operations Quality Specialist II's primary focus is leading department quality investigations to resolve the root cause and identify both corrective & preventative actions for top quality losses. Proactively leads quality improvements for the department.

Proactively drives quality improvements to achieve department right first time (RFT) and quality compliance goals. Participates in quality incident response, including initial response and containment, and applies Practical Problem Solving tools and principles to aid in root cause analysis and identification of corrective actions. Facilitate discussions between cross-functional teams (Quality, Tech Services, Engineering, etc.) in order to drive alignment on quality incident root cause and correction actions.

Aid in investigations of production related deviations of batches, preps, lots, equipment, and facilities to ensure all cGMPs, SOPs, product registrations, and customer requirements are met. Performs final functional area approval for operations owned deviation investigation reports to ensure report accuracy and alignment on root cause and correction action(s). When appropriate, revise and maintain Manufacturing procedures and forms to ensure GMP compliance. Support Manufacturing systems to proactively identify and address quality risks, including Daily Gemba process and Quality Suggestion Program. Track and analyze Quality metric data for Manufacturing department to drive RFT initiatives.

Participates in inspection readiness activities in Manufacturing Areas.

May assist in developing and maintaining quality and training systems, such as Digital Logbook system or eBPR system. Represent Operations when appropriate in PPI Kaizens and workshops

Models effective and constructive communication and interactions with technical departments both orally and in writing. Maintain acceptable proficiency in technical and non-technical (e.g. interpersonal) skills. Requires a passion for problem solving, attention to detail, good social skills, a sound understanding of cGMPs and Manufacturing/ Packaging. Ability to interact with the operations personnel, QA GMP Services, Process Engineers, Records/Release, Quality Control, QA Regulatory, Engineering.

Requirements:

• Bachelor's Degree in Engineering or Related Field is required.
• Previous experience in continuous improvement, Operations SME, and/or Technical SME.
• Quality, process and manufacturing investigation and technical writing experience is desired
• Equivalent combinations of education, training, and meaningful work experience may be considere
• Background in cGMP's requirements
• Lean Six Sigma problem solving skills
• Experience writing technical reports
• 3+ years experience in a quality role
• Autonomously prioritizes daily tasks with little to no oversight.
• Experienced in Microsoft Office Word, Excel and PowerPoint
• Is able to learn and navigate through investigation, quality and ERP systems
• Have flexibility to work various shifts times if needed to complete work content.
• Ability to inspire change and lead multiple projects
• Proficiency with English Language

Benefits:

We offer driven remuneration, annual incentive plan bonus scheme, healthcare, company pension, 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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

EEO/Reasonable Accommodation:

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and chip in to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.