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

Work Schedule

Environmental Conditions

Job Description

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

• 2-3 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

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.

What We Offer

We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!

Compensation

• Competitive Hourly Pay Rate
• Additional shift differential for 2nd shift and 3rd shift positions
• Annual performance-based bonus
• Annual merit performance-based increase

Excellent Benefits

• Benefits & Total Rewards Thermo Fisher Scientific
• Medical Dental & Vision benefits-effective Day 1
• Paid Time Off & Designated Paid Holidays
• 401K
• Tuition Reimbursement
• Employee Referral Bonus
• Career Advancement Opportunities

Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values - Integrity Intensity Innovation and Involvement - working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.