Work Schedule
Standard (Mon-Fri)
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
As part of the Thermo Fisher Scientific team, you will 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.
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The Operations Quality Specialist II is a critical member of the Operations Team. The Operations Quality Specialist II's primary focus is the writing of Minor deviations for quality incidents identified in Operations. This individual ensures the accuracy and on-time closure of these reports to adhere to quality compliance goals. Operations Quality Specialist II also assists in Major Operations department quality investigations as needed, as well as supporting other quality-related functions such as the execution of Effectiveness Checks and Functional Area Approval of Complaints.
Responsibilities include:
- 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.
- Responsible for the writing and submission of all Operations initiated Minor deviation reports to ensure on time closure.
- Participates in quality incident RAPID response, including initial response, containment, and data gathering.
- Facilitate discussions between Operations and cross-functional teams (Quality, Tech Services, Engineering, etc.) as needed in order to complete Minor investigations.
- Support data gathering for Major deviation investigations when needed.
- Perform Effectiveness Checks for Operations-owned CAPAs.
- Perform final functional area approval for Operations-owned Complaints to ensure report accuracy and alignment.
- Support revisions to Manufacturing procedures and forms to ensure GMP compliance as needed, such as revisions required following periodic review.
- Participates in inspection readiness activities in Manufacturing Areas when needed.
Strong Candidates demonstrate the following:
- Strong technical writing ability.
- 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, and 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.
- Autonomously prioritizes tasks with little to no oversight.
Preferred Experience/Skills:
Bachelor's Degree in Science, Engineering or Related Field is required.
Quality, process and manufacturing investigation and technical writing experience is required.
Previous experience in continuous improvement, Operations SME, and/or Technical SME is preferred
Background in cGMP's requirements is preferred.
Experienced in Microsoft Office Word, Excel and PowerPoint.
Is able to learn and navigate through investigation, quality and ERP systems, such as TrackWise and Documentum.
Have flexibility to work various shifts times if needed to complete work content.
Proficiency with English Language.
Equivalent combinations of education, training, and meaningful work experience may be considered.
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.