Quality Assurance Inspector - First Shift

Thermo Fisher Scientific•Allentown, PA

2d•Onsite

About The Position

When you are part of the team at Thermo Fisher Scientific, you’ll 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 you’ll 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. 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. 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.

Requirements

High School Diploma OR GED Required.
3+ years of relevant experience
Minimum 1 year of experience in a pharmaceutical or other regulated industry preferred
Familiarity with key Quality Systems (Change Control, Deviations, Complaints, Documentation Management).
Ability to read, understand, and follow SOPs and Work Instructions in a GMP setting.
Strong attention to detail and ability to work both independently and on cross-functional teams.
Willingness to work various shifts, including overtime, as business needs require.
Must not be allergic to penicillin or cephalosporin products.
Extensive standing and walking on packaging floor in order to monitor room activities.
This position requires standing, bending and lifting.
Incumbent must meet applicable visual acuity/color blindness standards to perform visual inspections in a cGMP environment

Responsibilities

Applies Good Manufacturing Practices (cGMP) in all areas of responsibility.
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.