Team Leader, Quality Assurance

Thermo Fisher Scientific•Allentown, PA

9d•Onsite

About The Position

The Quality Assurance Team Leader oversees the quality team and quality functions related to clinical packaging activities, including clinical products processed through primary and secondary packaging operations. The role works closely with relevant cross-functional groups at the Allentown, Pennsylvania site within Thermo Fisher Scientific’s Clinical Trials Division. The position reports to the Area Manager and involves reviewing operational quality matters, addressing issues, supporting continuous improvement, interacting with clients, and ensuring site adherence to established quality systems and applicable procedures. The Team Leader also performs Quality Inspector functions as part of a working-manager role. The schedule is Friday, Saturday, and Sunday, from 6:00 a.m. to 6:30 p.m. The employee may need to arrive early or stay late for transitions, and overtime may be required. Work takes place in a GMP-regulated packaging environment, including exposure to cold rooms and freezers and use of personal protective equipment as required.

Requirements

High school diploma or equivalent required.
At least 3 years of experience with a bachelor’s degree, or 5 years of experience in the pharmaceutical industry or a related regulated industry.
Experience in a leadership role.
Experience with quality systems, such as change control, deviations, complaint management, and documentation management.
Experience with risk assessment and root cause analysis.
Ability to lead and develop teams while fostering a quality-focused culture.
Strong knowledge of cGMP, FDA regulations, ICH guidelines, and quality systems.
Ability to perform as a working manager and carry out Quality Inspector functions daily.
Strong technical writing skills for SOPs, investigations, and regulatory documentation.
Strong interpersonal and communication skills for interacting with all levels of the organization.
Ability to work independently and read, understand, and follow GMP SOPs and policies.
Skills in decision-making, relationship-building, problem-solving, planning, and organizing.
Ability to communicate effectively verbally and in writing.
Ability to stand and walk extensively on the packaging floor, and to bend and lift up to 25 pounds occasionally and 10 pounds regularly.
Ability to work in cold temperatures for more than one hour at a time and in -20°F temperatures for at least 15 minutes at a time.
Ability to work in atmospheric conditions that may require special personal protective equipment.
Must meet applicable visual acuity and color-vision requirements for inspecting pharmaceutical products, components, and labels.

Nice To Haves

Bachelor’s degree, preferably with a technical or life sciences focus.

Responsibilities

Oversee the quality team and quality functions supporting clinical packaging operations.
Work with the Area Manager to review significant operational matters related to quality.
Ensure issues are resolved promptly and corrective actions are implemented.
Participate in continuous improvement initiatives.
Interact with clients on quality issues and represent the company’s quality concepts.
Author and revise relevant procedures, comply with them, and document activities as needed.
Escalate issues that may affect product quality or compliance to management.
Conduct activities safely and effectively.
Perform Quality Inspector functions daily as a working manager.
Carry out other duties assigned to meet business needs.