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Quality Compliance Specialist III

Company: Thermo Fisher Scientific
Location: Eugene
Posted on: November 22, 2022

Job Description:

**Job Title: Quality Compliance Specialist****Requisition ID: 215106BR**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 live 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.**Location/Division Specific Information****_Position is located in Carlsbad-CA: Microbial Manufacturing Services (MMS)_****_Successful candidate must be willing to relocate._**At MMS a new Business Unit within Thermo Fisher Scientific's Pharma Services Group, we deliver from process development through commercial supply, the expertise, and resources necessary to help clients deliver innovative plasmid-based therapeutics as critical raw materials, drug substances, and drug products. Placed in the forefront of our leading and cutting-edge Cell and Gene Therapy businesses enabling clients to cure genetic, rare, and otherwise untreatable diseases as their CDMO of choice.**How will you make an impact?**The Compliance specialist in this role will be part of a cohesive team responsible for Deviations, CAPAs, Internal and External Audit, Supplier Quality, Customer Complaint, and Change Control for all phases of manufacturing. The successful candidate will have strong competency in attention to detail; high level of customer focus; able to make quality decisions; excellent written and verbal communication, and strong technical acumen. This position interacts with managers in all departments in developing solutions and providing timely and accurate communication.**What will you do?**+ Conduct Internal, and Supplier Quality audits+ Support site inspection readiness+ Review and approve Deviations, Corrective and Preventive Actions (CAPA), and Change Controls+ Review and approve a wide variety of GMP related documents and provide appropriate feedback when necessary.+ Assist in the creation and modification of Quality System procedures and related documentation+ Work independently with minimal supervision and direction.+ Practice and promote safe work habits and adhere to safety procedures and guidelines+ Participate in initiatives to support innovation and continuous improvement activities+ Facilitate and participate in observation responses and tracking CAPAs to completion including+ Scheduling responses meetings+ Assist in writing responses and CAPAs+ Approval of Quality Systems records+ Support and Facilitate Site Management Review and metrics+ Supports corporate standard gap assessment**How will you get there?**Education and Experience+ Bachelor's degree in a Scientific discipline (Life Sciences, Biotechnology, or equivalent) plus a minimum 3+ years' experience in FDA regulated environment.+ 3+ years of experience within Compliance or Supplier Quality+ Experience with Trackwise and Documentum systems is a plus.+ At least 2 years of experience in conducting internal audits of Quality Systems is required.+ Strong understanding of change management within Quality System+ Ability to apply GMP/GLP regulations and other international guidelines to all aspects of the position.+ Working knowledge of controlled document and data systems+ Must have experience as an independent, results oriented individual contributor+ Technical knowledge of biopharmaceutical manufacturing is desirable.+ Demonstrate ability to make key decisions.+ Demonstrate ability to work on multiple assignments effectively.+ Excellent organizational skills and problem-solving abilities.+ Able to aseptically gown and work in environmental clean rooms, as needed.+ Team player with the ability to work collaboratively with other functions, gaining their cooperation in dealing with issues of complianceOur 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.Apply today! http://jobs.thermofisher.comThermo 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.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.

Keywords: Thermo Fisher Scientific, Eugene , Quality Compliance Specialist III, Other , Eugene, Oregon

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