Quality Specialist III

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.