Sr QA Technician: Batch Records Release (8hr days, Mon-Fri) [Remote]

JOB DESCRIPTION

Work Schedule

First Shift (Days)

Environmental Conditions

Office

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 independently performs batch record review and collaborates with operations to resolve documentation issues. Gains exposure to deviation assessments and quality systems. Day shift hours are Monday-Friday, 8am-5pm.

Key Responsibilities:

• Review complex or high-risk production records for GMP compliance.

• Collaborate with cross-functional teams (Manufacturing, QC) to ensure timely batch release.

• Provide guidance and on-the-job training for new technicians.

• Assist in preparation for regulatory and client audits.

• Lead initiatives to streamline batch review and electronic systems.

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

Education

• High School diploma / equivalent minimally required.

• Associates degree or higher in Science or Technology is preferred

Experience

• Required: Minimum of 2 years of work experience in QA or QC or related field

• Required: Experience in a cGMP environment

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

Knowledge, Skills, Abilities

• Strong understanding of cGMP and batch documentation flow.

• Good verbal/written communication skills to partner with production teams.

• Excels in a team environment.

• Basic math skills.

• Attention to detail while maintaining quality.

• Ability to follow SOPs.

Physical Requirements/Work Environment

• Use Personal Protective Equipment (PPE) and understand chemical hygiene.

• Infrequently lift and manipulate up to 50 pounds max unassisted.

• Stand and move about including reaching, bending, stooping, grasping.

• Use hand tools and equipment including forceful gripping, grasping, pushing and pulling.

• 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.