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Clinical Quality Assurance Specialist

2 months ago

Allentown, Pennsylvania, United States Thermo Fisher Scientific Full time
Work Schedule

Environmental Conditions

Job Overview


At Thermo Fisher Scientific, you will engage in impactful work that contributes positively on a global scale.

Join our dedicated team in fulfilling our Mission daily, empowering our clients to enhance global health, cleanliness, and safety.

We equip our international teams with the necessary resources to reach personal career aspirations while advancing scientific endeavors by developing solutions for some of the world's most pressing challenges, such as environmental protection, food safety, and cancer research.

About Fisher Clinical Services


Fisher Clinical Services, a division of Thermo Fisher Scientific, is a premier provider of global clinical supply chain solutions.
With a steadfast commitment to service, scientific excellence, and process optimization, we are driven by individuals who possess a strong dedication to quality, ethical responsibility, and unparalleled expertise.

Our focus is exclusively on meeting the packaging and distribution needs of clinical trials worldwide.

Location/Division Specific Information


CTD collaborates with pharmaceutical and biotech partners globally to ensure patients receive the correct therapies in appropriate doses at the right time—a principle we uphold as "There is a Patient Waiting." Our diverse range of services encompasses project management, packaging, distribution, transportation management, specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage, and more.

With over 3000 employees across more than 15 countries, we work diligently every day, understanding the significance of our contributions.


Discover Meaningful Work:


As a member of our global team, your role directly supports our mission; enabling our clients to foster a healthier, cleaner, and safer world.


A Day in the Life:


The Clinical Quality Assurance Specialist is accountable for ensuring the quality of clinical products throughout primary and secondary packaging, warehousing, and distribution operations.


This position necessitates meticulous attention to detail, a strong ability to identify defects and errors, effective verbal and written communication skills, and collaboration with cross-functional teams to solve problems.


Keys to Success:

Education:
Associate's degree or High School Diploma with a minimum of 2 years of relevant experience.

Experience:
At least 1 year of experience in the pharmaceutical industry or a related regulated field, alongside a high school diploma.

Familiarity with Quality Systems (Change Control, deviations, complaint management, documentation management, etc.).

Application of Good Manufacturing Practices (cGMP) in all responsibilities.

Exhibits and promotes the company vision.

Conducts approval of specifications and incoming inspections on materials (e.g., drugs, components) and distribution shipments.

Performs material and process inspections and sampling.

Reviews and approves Packaging Electronic Production Orders.

Engages in continuous improvement initiatives and assists with root cause analysis for nonconforming issues.

Authors, revises, and adheres to all relevant SOPs and Work Instructions, documenting activities as necessary.


Identifies and escalates issues that may impact product quality/compliance to the Team Leader and/or Management.

Ensures timely resolution of issues and implementation of corrective actions.

Conducts all activities safely and efficiently.

Additional duties may be assigned to fulfill business needs.

Knowledge, Skills, Abilities:


A minimum of 1 year of experience in the pharmaceutical industry or a related regulated field, along with a high school diploma.

Familiarity with Quality Systems (Change Control, deviations, complaint management, documentation management, etc.).

Ability to work in a refrigerated environment (35F to 46F) with provided protective gear.

Ability to work in a freezer (-20F) environment with provided protective gear.

Ability to work in potent compound suites with provided protective gear (PPE).

Strong reasoning and problem-solving skills, basic math skills, effective communication skills, and basic computer proficiency.

Willingness to work various shifts and overtime based on business needs.

Ability to work independently.

Mastery of skills required to read, understand, and comply with the SOPs and policies of a GMP environment.

Physical Requirements:

Must not have allergies to penicillin or cephalosporin products.

Extensive standing and walking on the packaging floor to monitor room activities.

Work schedule is Monday through Friday, 8 hours per day. Additional overtime and weekend work may be required.

This position requires standing, bending, and lifting. Occasional lifting of up to 25lbs of materials and regular lifting of 10lbs of materials.

The position involves exposure to cold temperatures for extended periods.

The position may involve exposure to -20F temperatures for brief periods.

The position may require special personal protective equipment due to atmospheric conditions.

Incumbent must meet applicable visual acuity/color blindness standards to perform visual inspections in a cGMP environment.

Our Mission is to empower our clients to create a healthier, cleaner, and safer world.

As a unified team of over 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - collaborating to accelerate research, tackle complex scientific challenges, drive technological advancements, and support patients in need.

#StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued.

Apply today


Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

Accessibility/Disability Access:

Job Seekers with a Disability:
Thermo Fisher Scientific provides accessibility services for job seekers needing accommodations during the application process. This may include assistance for individuals with hearing, vision, mobility, or cognitive impairments.

If you are a job seeker with a disability, or assisting someone with a disability, and require accessibility assistance or accommodations to apply for one of our positions, please submit a request.

Please include your contact information and specific details about your required accommodation to support you during the application process.