Sr QA Technician

at  Thermo Fisher Scientific

GROUP/DIVISION SUMMARY

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.

POSITION SUMMARY

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.

QUALIFICATIONS:

• High School Diploma with 4 years of relevant experience required.
• Equivalent combinations of education, training, and relevant work experience may be considered.
• 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.
• 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 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.

• Evaluates batch record documentation, confers with Production and Quality Assurance to assure compliance with cGMPs, Standard Operating Procedures (SOPs), and regulatory requirements.
• Assures compliance of all operations to SOPs, standard and GMPs through follow-ups to process and other findings. Serves as GMP resource to Production and other internal customers to prevent regulatory liability or client dissatisfaction.
• Provides technical and regulatory expertise to Production.
• Performs analysis on batch record data. Tracks batch record errors and process flow to improve accuracy, efficiencies of the process, and GMP awareness.
• Works in a safe and responsible manner in order to create an injury-free and incident-free workplace.
• Follows all job-related safety and other training requirements.
• Performs other duties as assigned