Thermo Fisher Scientific Lead QA Technician in Greenville, North Carolina

Job Description

Summary:

Provides direct quality support to ensure compliance with regulations that govern pharmaceuticals.

Ensures the site can operate without regulatory actions that impede product quality, cause product

stoppages, or reduce customer satisfaction.

Essential Functions:

  1. Complies with all job-related safety and other training requirements. Employee’s responsibility to work in a

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

  1. Processes and projects of moderate complexity, perform compliance assessments, make decisions regarding

regulatory requirements; ensures adherence to current regulations with little dependence on others.

  1. Provides leadership and team participation as assigned for assignments related to quality initiatives and

compliance improvements, product transfers, facility expansions, etc.

  1. Performs document reviews and made determinations as to whether work performed meets current procedures

and regulatory expectations. Communicates and coordinates with other departments as required to resolve

issues and compliance concerns detected during review.

  1. Conducts risk assessments and take appropriate actions during quality oversight activities (e.g. during

review/approval) to ensure adequate controls in relation to the level of product quality, safety and business

risks.

  1. Performs QA batch disposition (release) decisions.

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

  3. Performs other duties as assigned.

Education:

Bachelor’s degree in related field (Computer science, Chemistry, Biology, or other technical or physical/life

science) is required.

Experience:

Three years of relevant experience is preferred.

Equivalency :

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

Competencies:

Multiple computer skills including working experience with MS Office applications such as Word and Excel and

general experience in computer systems associated with quality assurance functions such as lot review, SOP

review and approval, lab results reviews (LIMS), disposition of product and validation document reviews. 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.

Outstanding attention to detail and organizational skills. Self-starter, mature, independent and dependable. Ability

to work in a fast paced environment under pressure, able to multi-task and is results-oriented. Demonstrated

ability to manage and lead professional staff in order to achieve goals, evaluate and resolve complex technical

problems. Ability to motivate, energize, and retain key staff by direct interactions with supervisors and staff.

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations;

ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry,

move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and

type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and

read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for

prolonged periods of time.

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.