Job Title: Lead QA Technician
Requisition ID: 132004

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

Location: Greenville, NC

How will you make an impact?
This position will be responsible for ensuring quality execution of sterile operations with respect to manufacturing, filling, packaging and inspection, and associated non batch specific activities in the Steriles facility for both commercial and product development services products. Additionally, this position will provide quality guidance and expertise for implementation of practical process improvements and continuous improvement initiatives. Primary responsibilities require consistent production floor presence which necessitates physical fitness for prolonged standing, walking, and repetitive bending, proficiency in both aseptic and non-aseptic gowning, and knowledge of aseptic technique. Position requires 12 hour day shift schedule on a 2-2-3 rotation with every other weekend off.

What will you do?

• Perform daily quality assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies and assure quality and compliance as required by site procedures and cGMPs.
• Daily interaction with personnel to assist with troubleshooting, documentation corrections/notes, and guidance with aseptic technique
• Fosters quality culture by aiding personnel in understanding application of policies and controls
• Participates in rapid response and provides quality guidance and quality decision making for RAPID events
• Ensures escalation of deviation events to the appropriate area and quality management
• Performs quality review and approval of procedures, training documents, and forms of moderate to high complexity
• Performs quality review and approval of deviation and change control of low to moderate complexity
• Participates as the quality assurance representative in root cause analysis to support deviation investigations of low to moderate complexity
• Performs quality batch record review
• Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives

How will you get there?
Education:

• Bachelor’s degree, preferably in technology, engineering or science related field
• Associates degree, minimum in technology, engineering or science related field
• Equivalent combinations of education, training, and relevant work experience may be considered

Experience:

• A minimum of 2 years experience in Quality Assurance or Quality Control or Operations/Manufacturing.
• Previous experience in pharmaceutical industry; preferably aseptic or steriles processes strongly preferred, experience in other regulated environments may be considered (i.e. ISO 9001)
• Professional certifications (ex: CQA) and training (Six Sigma) are a plus

Knowledge, Skills, Abilities:

• Ability to gather data, analyze & troubleshoot process issues, equipment problems along with production leadership
• Self-driven, demonstrated ownership & responsibility; Ability to lead, support & motivate a team
• Technical Writing experience

• Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 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, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues 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 and Patheon. For more information, please visit www.thermofisher.com.
  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.