Thermo Fisher Scientific

Sr. QA Technician: Records Specialist (8hr days, Monday-Friday)

Thermo Fisher Scientific  •  Greenville, NC (Onsite)  •  7 hours ago
Apply
AI can make mistakes so check important info. Chat history is never stored.

Job Description

Work Schedule

First Shift (Days)

Environmental Conditions

Office

Location/Division Specific Information

As part of the Drug Product Division (DPD), the Greenville, North Carolina site is a multi-purpose pharmaceutical development, manufacturing, and packaging campus. The operation specializes in taking both sterile injectable and oral solid dose drug products from development phase through to commercialization.

How Will You Make an Impact

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. Day shift hours are Monday-Friday, 8am-5pm.

A Day in the Life

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

  • Provides leadership and team participation as assigned for assignments related to quality initiatives and compliance improvements, product transfers, facility expansions, etc.

  • Advances deviation events to the appropriate area and quality management

Education

  • High School Diploma or equivalent 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 relevant 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/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.

Thermo Fisher Scientific

About Thermo Fisher Scientific

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

For more information, please visit www.thermofisher.com.

Industry
Biotech & Life Sciences
Company Size
10,000+ employees
Headquarters
Waltham, MA
Year Founded
Unknown
Social Media