About The Position

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Senior Associate Microbiology, Analytical Science & Technology supporting the Quality & Regulatory Affairs function, you will be trusted to work on performing microbiological analyses to ensure continuous manufacturing and product readiness. You will lead in-house lab validation studies, assist in training, and support Quality Control auditors. Complex tasks are conducted using scientific principles to drive problem-solving and innovation at our Manufacturing Facility in Fort Worth North, TX! In this role, a typical day will include: Extensive knowledge of aseptic and sterile pharmaceutical practices, along with a strong understanding of regulatory requirements.

Requirements

  • Bachelor's Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+16yrs; M.S.+0 yrs) The ability to fluently read, write, understand and communicate in English
  • 2 Years of Relevant Experience
  • 1 Years of Demonstrated Leadership
  • Work Hours: Monday - Friday, 8:00 AM - 5:00 PM CST
  • Location: Onsite
  • Travel Requirements: 0 - 10%
  • Relocation Assistance: None
  • Sponsorship Available: No

Nice To Haves

  • Strong knowledge of aseptic/sterile pharmaceutical experience and pharmaceutical regulatory requirements.
  • Excellent communication skills, in both verbal and written form.
  • Highly attentive to details and comfortable speaking up.
  • Ability to work overtime and flexible work hours to meet department goals.

Responsibilities

  • Provide technical support during investigations (e.g., sterility failures, contamination events).
  • Ensure adherence to regulatory requirements (USP, FDA, EMA, ISO).
  • Perform and oversee testing for Bioburden, Endotoxin, Sterility, AET, and Growth Promotion on raw materials, in-process samples, and finished products.
  • Perform method development and validation for microbiological assays.
  • Review and approve microbiological data for completeness, accuracy, and cGMP compliance. Interpret test results and ensure proper documentation per GDP and GLP standards.
  • Perform Equipment Qualifications and maintain lab equipment to ensure compliance with current Good Laboratory Practices (cGxP) and Standard Operating Procedures (SOPs).
  • Participate in internal and external audits, including responding to observations and supporting CAPAs.
  • Troubleshoot and resolve complex issues using advanced technical knowledge and analytical skills.
  • Lead or contribute to continuous improvement projects in microbiology workflows.
  • Collaborate with cross-functional teams (QA, QC, Production, Validation) to integrate lab results into the manufacturing process and drive innovation
  • Adhere to Good Laboratory Practices (GxP) regulations by following SOPs, maintaining accurate documentation, and ensuring rigorous quality control.

Benefits

  • See your career like never before with focused growth and development opportunities.
  • Join Alcon's mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
  • Alcon provides a robust benefits package including health and life insurance, retirement, flexible time off for exempt associates, paid time off for hourly associates, and much more!

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume

What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Industry

Computer and Electronic Product Manufacturing

Number of Employees

5,001-10,000 employees

© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service