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Job Description

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.

Fisher Clinical Services, part of Thermo Fisher Scientific, is a leading provider of global clinical supply chain. With unwavering commitment to service, science and process engineering, Fisher Clinical Services is powered by people with an exceptional commitment to quality, deeply instilled ethics of personal responsibility and unrivaled expertise. We are exclusively focused on serving the packaging and distribution requirements of clinical trials across the world. Whether planning, packaging, labeling, storing, or distributing the important supplies needed to perform clinical research, for more than 27 years Fisher Clinical Services has been committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability and sustainability standards.

Location/Division Specific Information

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 unique 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:

As part of our global team, what you do contributes directly to our mission; enabling our customers to make the world healthier, cleaner and safer.

A day in the Life:

• Quality Assurance Inspector responsible for the quality of clinical products processed through primary and secondary packaging, warehouse, and distribution operations.
• This role requires attention to details, the keen ability to discover defects and errors, ability to communicate both verbally and written, and collaborate with cross-functional groups in problem solving.

• Associates degree or High School Diploma with 2 years of experience.

• 1+ years of experience in Pharmaceutical or of a related, regulated industry and a high school diploma.
• Familiar with Quality Systems (Change Control, deviations, complaint management, documentation management, among others).
• Applies Good Manufacturing Practices (cGMP) in all areas of responsibility.
• Demonstrates and promotes the company vision.
• Performs approval of specifications and incoming inspections on material (i.e. drug, components) and distribution shipments.
• Performs material and process inspections and samplings.
• Review and approve Packaging Electronic Production Orders.
• Participates in continuous improvement initiatives and assists with root cause investigations for nonconforming issues.
• Author's, revises, and complies with all relevant SOP's and Work Instructions and properly documents activities when necessary.
• Resolve and assure that issues potentially affecting product quality/compliance are escalated to the attention of the Team Leader and/or Management.
• Assures that issues are resolved in a timely manner and corrective actions are implemented accordingly.
• Performs all activities in a safe and efficient manner.
• Other duties may be assigned to meet business needs.

• A minimum of 1 year of experience in Pharmaceutical or of a related, regulated industry and a high school diploma.
• Familiar with Quality Systems (Change Control, deviations, complaint management, documentation management, among others).
• Must be able to work in a refrigerated environment (35F to 46F) with provided protective wear.
• Must be able to work in a freezer (-20F) environment with provided protective wear.
• Must be able to work in potent compound suites with provided protective wear (PPE).
• Good reasoning and problem-solving skills, basic math skills, good communication skills, basic computer skills.
• Must be willing to work various shifts and overtime depending on business needs.
• Must be able to work independently.
• Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.

• Must not be allergic to penicillin or cephalosporin products.
• Extensive standing and walking on packaging floor in order to monitor room activities.
• Work schedule, Monday through Friday, 8 hours per day. Additional overtime and weekend (Saturday or Sunday) work may be required.
• This position requires standing, bending and lifting. Exerting and lifting up to 25lbs of materials occasionally, and 10lbs of materials regularly.
• The position is exposed to cold temperatures for more than one hour at a time.
• The position is exposed to -20F temperatures for at least 15 minutes at a time.
• The position will be exposed to atmospheric conditions could require special personal protection equipment.
• Incumbent must meet applicable visual acuity/color blindness standards to perform visual inspections in a cGMP environment.