Quality Specialist II

Thermo Fisher Scientific Inc

Florence, SC

JOB DETAILS
SKILLS
Analysis Skills, Auditing, Biology, Biotech and Pharmaceutical, Cancer, Change Control, Chemistry, Cleanroom, Communication Skills, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Documentation Review, Drug Manufacturing, External Audit, FDA (Food and Drug Administration), FDA Requirements, Food Safety, GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), ISO 9001, Internal Audit, International Health, Lift/Move 25 Pounds, Maintain Compliance, Manufacturing Operations, Manufacturing Requirements, Microsoft Office, Operational Support, Organizational Skills, Physical Demands, Presentation/Verbal Skills, Problem Solving Skills, Project/Program Management, Quality Assurance, Quality Management, Regulations, Regulatory Compliance, Regulatory Requirements, Root Cause Analysis, Support Documentation, Systems Maintenance, Technical Writing, Writing Skills
LOCATION
Florence, SC
POSTED
11 days ago

Work Schedule

Standard (Mon-Fri)

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.

Excellent Benefits Package

Review our company's Total Rewards

Medical, Dental, & Vision benefits-effective Day 1

Paid Time Off & Holidays

401K Company Match up to 5%

Tuition Reimbursement - eligible after 90 days!

Employee Referral Bonus

Employee Discount Program

Recognition Program

Charitable Gift Matching

Company Paid Parental Leave

Career Advancement Opportunities

Discover Impactful Work:

Join Thermo Fisher Scientific as a Quality Specialist II and contribute to global healthcare and scientific advancement. In this role, you'll ensure compliance with GMP standards, FDA regulations, and international quality requirements while supporting manufacturing operations across multiple product lines. Working with cross-functional teams, you'll implement continuous improvement initiatives, conduct investigations, and maintain quality management systems that enable our mission of making the world healthier, cleaner, and safer.

A Day in the Life:

Support manufacturing operations through quality oversight, deviation investigations, CAPA management, change control activities, audit support, documentation review, and continuous improvement initiatives. Partner with cross-functional teams to ensure compliance with GMP, FDA, ISO, and internal quality requirements.

Keys to Success:

Education

  • Advanced degree with no prior experience, or Bachelor's degree with 2 years of experience in pharmaceutical/biotech manufacturing, quality assurance, or related GMP environment
  • Preferred fields of study: Biology, Chemistry, Engineering, Life Sciences, or related scientific field

Knowledge, Skills, Abilities

  • Knowledge of cGMP regulations, ISO standards (9001/13485), and international regulatory requirements
  • Experience with quality management systems and documentation (TrackWise, MasterControl, or equivalent)
  • Experience in deviation investigations, CAPA, change control, and root cause analysis
  • Proficient in Microsoft Office suite and quality management software systems
  • Technical writing and documentation skills
  • Analytical and problem-solving abilities
  • Clear verbal and written communication skills
  • Ability to work independently and collaboratively in cross-functional teams
  • Experience conducting internal audits and supporting external regulatory inspections
  • Project management and organizational skills
  • Ability to work in cleanroom environments and follow gowning procedures where required
  • Additional language skills may be beneficial

Additional Requirements

  • Must be able to work various shifts to support manufacturing operations
  • Physical requirements include standing/walking for extended periods and occasional lifting up to 25 lbs

About the Company

T

Thermo Fisher Scientific Inc

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.

All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.

Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer.

COMPANY SIZE
10,000 employees or more
INDUSTRY
All
WEBSITE
https://corporate.thermofisher.com/en/home.html