Sr QA Technician (8hr days, Monday-Friday)

JOB DESCRIPTION

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information:
Greenville, NC/The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

A Day in the Life:

The Sr. Quality Technician, Provides direct quality support to ensure compliance with regulations that govern pharmaceuticals. Ensures the site operates in compliance with regulatory standards that ensures product quality, avoids stoppages and reinforces customer satisfaction. Typical shift hours are 8:00am-5:00pm, Monday through Friday with overtime expected.

Key Responsibilities:

• Follow all job-related safety and other training requirements.

• Performs document reviews and makes 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.

• 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.

• Advances deviation events to the appropriate area and quality management.

• Performs processes of moderate complexity, ensuring adherence to current regulations with little dependence on others.

Education:

• High school diploma or equivalent required.

• Associates degree or higher in Science or Technology is preferred 

Experience: 

• Required: Minimum of 2 years of experience in direct interaction with operations/laboratory or related STEM experience required ; experience in Quality Assurance, Quality control or Operations/Manufacturing in a regulated industry and direct interaction with operations/laboratory is strongly preferred.

• Required: Experience in a cGMP environment

• Equivalent combinations of education, training, and meaningful work experience may be considered

Knowledge, Skills, Abilities:

• Outstanding attention to detail and organizational skills.

• Self-starter, mature, independent and reliable

• Ability to work in a fast paced environment under pressure and able to multi-task.

• Effective time management and prioritization skills.

• Requires discretion and independent judgment.

• Highly effective verbal and written communication skills.

• Ability to work on a team and help lead that team to be successful and productive.

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 pound 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. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally.