Lead QA Technician (Batch Record Review)
Thermo Fisher Scientific

Work Schedule
First Shift (Days)

Environmental Conditions
Office

Job Description

The Lead QA Technician provides an outstanding opportunity to become part of a best-in-class team dedicated to excellence in the pharmaceutical industry. This role is pivotal in ensuring detailed adherence to exacting regulations, thereby maintaining the highest standards of product quality and customer happiness.

Key Responsibilities:

• Cultivate a quality culture by aiding personnel in understanding the application of policies and controls.
  
• Advance deviation events to the appropriate area and quality management.
  
• Perform processes and projects of moderate complexity, ensuring adherence to current regulations with minimal dependence on others.
  
• Provide leadership and team participation as assigned for quality initiatives, compliance improvements, product transfers, and facility expansions.
  
• Perform document reviews and make determinations as to whether work performed meets current procedures and regulatory expectations.
  
• Communicate and coordinate with other departments to resolve issues and compliance concerns detected during review.
  
• Conduct risk assessments and take appropriate actions during quality oversight activities to ensure adequate controls relative to product quality, safety, and business risks.
  
• Subject Matter Expert in batch records
  
• Perform QA batch disposition (release) decisions.
  

Qualifications:

Education

Associate Degree required, preferably in technology, engineering, scientific related field or related field. Bachelor degree in related field (Computer science, Chemistry, Biology, or other technical or physical/life science) is preferred.

Experience

• 2-3 years of related experience if candidate has an associate degree, preferably in direct interaction with operations/laboratory or related STEM experience.
  
• Up to 2 years of related experience if candidate has obtained a Bachelor degree.
  
• Experience in Quality Assurance, Quality control or Operations/Manufacturing in a regulated industry and direct interaction with operations/laboratory is preferred.
  
• Equivalent combinations of education, training, and relevant work experience may be considered if at least an Associate degree is obtained.
  

Knowledge, Skills, Abilities

• Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters.
  
• Highly effective verbal and written communication skills.
  
• Outstanding attention to detail and organizational skills
  
• Self-starter, mature, independent and dependable.
  
• Demonstrated ability to mentor professional staff in order to achieve goals, evaluate and resolve complex technical problems.
  
• Ability to command authority and remain firm in complex situations.
  
• Ability to motivate, energize, and retain key staff by direct interactions with supervisors and staff.
  
• Capable of thriving in a fast-paced environment, handling pressure, and prioritising multiple tasks efficiently.
  
• Requires discretion and independent judgment.
  
• Ability to respond disciplined and rationally under pressure.
  
• Multiple computer skills including working experience with MS Office applications such as Word and Excel and general experience in computer systems associated with quality systems such as lot review, SOP review and approval, lab results reviews (LIMS), disposition of product and validation document reviews.
  

We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team.

At Thermo Fisher Scientific, each one of our 100,000+ extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

Apply today!

This job has expired.