Job Description
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP)
Safety Standards, Office Job Description Title:
Quality Specialist III 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. Division/Site Specific Information Role reports to the Allentown, PA site and reports to the Clinical Trials Division (CTD). CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time - a concept that we internally embrace as "There is a Patient Waiting." Our outstanding blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more. Our more than 3000 employees in over 15 countries work hard every day knowing that what they do matters. Discover Impactful Work:
Join Thermo Fisher Scientific in ensuring the highest quality standards across our operations. As a Quality Specialist III, you will maintain regulatory compliance and drive continuous improvement of quality systems to support our mission of enabling customers to make the world healthier, cleaner and safer. A Day in the Life For Deviations/Complaints this requires strong analytical thinking skills, root cause analysis understanding and the ability to partner with colleagues to determine appropriate corrective and preventative actions. For Change Controls this requires being a facilitator of live Change Control Board and the ability to assess changes and their impact to quality/compliance. Decision making needs to be based on strong quality/ compliance principals and appropriate GMP Regulations. Keys to Success:
Education BS degree highly preferred. Preferred Fields of Study:
Life Sciences, Engineering, Chemistry, Biology or related technical field High school diploma or equivalent required. Experience Bachelor's Degree plus 3-5 years of experience in quality assurance/quality control within regulated industries (pharmaceutical, medical device, biotech preferred). Without BS degree 5-7 years of experience accepted. Project management experience preferred. Experience with quality management systems, CAPA processes, deviation management, and change control. Knowledge, Skills, Abilities Strong knowledge of GMP/GxP regulations, ISO standards (9001/13485), and other relevant quality system requirements Demonstrated expertise in root cause analysis, investigation techniques, and corrective action implementation Proficiency in statistical analysis, data trending, and quality metrics reporting Strong technical writing skills for authoring SOPs, investigation reports, and other quality documentation Advanced problem-solving abilities and attention to detail Excellent verbal and written communication skills Strong interpersonal skills with ability to collaborate across functions and levels Proficiency with quality systems software (TrackWise, Document Control Systems) and Microsoft Office Suite Ability to work independently and guide cross-functional teams Physical ability to work in manufacturing environments with PPE requirements as needed Knowledge of risk assessment methodologies and continuous improvement tools Benefits We offer competitive remuneration, annual incentive plan bonus scheme, 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. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
