Thermo Fisher Scientific Group Leader, Lab Services Raw Material Sampling in Greenville, North Carolina

Job Description

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Responsibilities

  1. Manages staff responsible for the day-to-day operations of multiple quality operations. Reviews departures

from procedures and recommend action for approval by Sr. Group Leader/Manager/Director. Approves

Current Good Manufacturing Practices (cGMP) records.

  1. Monitors the performance of staff such that corporate and business goals are met. Meets throughput goals

for batch dispositions, assessment, investigations, and validation projects. Recruits and develops staff.

Trains staff. Applies progressive discipline programs as required.

  1. Develops and implements policies and procedures. Implements approved changes in collaboration with labs,

production, regulatory, client and Quality. Ensures that work is appropriately documented per cGMP.

Makes decisions regarding acceptability of results and documentation. Identifies issues requiring review by

management.

  1. Establishes actions and implement systems to achieve process improvements and efficiencies to address

shortcomings in processes and systems. Serves as principle in problem solving, failure analysis and quality

or process system design activities related to product quality. Evaluates protocols, procedures, documents

and results for scientific and/or business merit. Ensures areas of responsibility are compliant with industry

standards and trends.

  1. Drafts submission ready sections of regulatory dossiers for drug products for approval by management.

Drafts specification rationales for drug products. Drafts standard operating procedures. Writes appropriate

reports and correspondence. As needed, write reports for clients.

  1. Maintains knowledge of public standards, regulatory trends and cGMPs. Serves as the technical and

regulatory expert in their operational area. Backs up to key regulatory inspection contact. Participates in

negotiations with clients, regulatory reviewers and inspectors on issues to assure timely resolution of issues

or approval of client applications.

  1. Works in a safe and responsible manner in order to create an injury-free and incident-free workplace.

  2. Complies with all job-related safety and other training requirements.

  3. Performs other duties as assigned.

Qualifications

Bachelor’s degree in a scientific or related discipline is required.

Four years of relevant experience that includes two years of leadership experience is preferred.

Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:

Knowledge of methods development approaches, analytical validations, quality control statistics, documentation

and adherence to SOP’s. Ability to write quality technical reports and give effective oral presentations. Ability to

effectively collaborate with others to achieve team goals and expectations A genuine interest in researching and

implementation of new approaches to analysis. Outstanding attention to detail and organizational skills. Selfstarter,

mature, independent and dependable. Ability to work in a fast paced environment under pressure, able to

multi-task and is results-oriented. Demonstrates ability to maintain a high degree of confidentiality. Effective

time management and prioritization skills. Requires discretion and independent judgment. Very high degree of

interpersonal skills to establish and maintain effective working relationships with employees and the public,

including tact to handle sensitive matters. Highly effective verbal and written communication skills.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

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