Sr. QA Technician (8hr days, Monday-Friday)
Thermo Fisher
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. Typical shift hours are 8:00am-5:00pm, Monday through Friday with overtime expected.
Job description
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. Typical shift hours are 8:00am-5:00pm, Monday through Friday with overtime expected.
A Day in the Life
- Follows 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 takes appropriate actions during quality oversight activities 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.
Knowledge, Skills, Abilities
- Outstanding attention to detail and organizational skills.
- Good verbal and written communication skills (legible handwriting).
- Self-starter, mature, independent and reliable.
- Ability to adapt to a changing environment quickly and easily.
- 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.
Requirements
- High school diploma or equivalent minimally required
- Associates degree or higher in Science or Technology preferred
- 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 strongly preferred
- Experience in a cGMP environment required
- Outstanding attention to detail and organizational skills
- Good verbal and written communication skills
- Self-starter, mature, independent and reliable
- Ability to adapt to a changing environment quickly and easily
- 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
- Ability to work on a team and help lead that team to be successful and productive
Company overview
Thermo Fisher Scientific is a global leader in serving science, with annual revenue of approximately $40 billion. The company provides a comprehensive portfolio of analytical instruments, equipment, reagents and consumables, software, and services for research, analysis, discovery, and diagnostics. Their mission is to enable customers to make the world healthier, cleaner, and safer by accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies, and increasing laboratory productivity. Thermo Fisher serves pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions, and government agencies worldwide. The company operates through four business segments: Life Sciences Solutions, Analytical Instruments, Specialty Diagnostics, and Laboratory Products and Services.