Job Description

When you are part of the team at Thermo Fisher Scientific, youll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and youll be supported in achieving your career goals.

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. http://www.fisherclinicalservices.com/

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.

What will you do?

Our company seeks a 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.

Shift Information: Second Shift: 2:15-10:30 PM Monday-Friday;
overtime could possibly involve weekend work

How will you get here?

Education

Associates degree is required and 1 year of experience in a GMP environment.
OR
High School Diploma is required with 2 years of pharmaceutical experience.

Responsibilities

* 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.
* Participates in continuous improvement initiatives and assists with root cause investigations for nonconforming issues.
* Authors, revises, and complies with all relevant SOPs 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

Knowledge, Skills, Abilities

* 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.

Physical Requirements

* 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

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com