PDU Lab Analyst

PDU Lab Analyst

The "PDU Lab Analyst" will be based in Research Blvd Austin, Texas, reporting to Cecilia Martinez Coleman.

Performs laboratory setup, preparation, and testing activities to support medical device process confirmation testing (Patch Delivery Unit) in an FDA 21 CFR Part 820 and ISO 9001 regulated laboratory environment. Ensures testing is completed accurately, on time, and in compliance with internal and customer quality, safety, and documentation requirements while supporting overall efficient laboratory operations and product release.

The experience we're looking to add to our team:

• Perform routine laboratory testing using approved standard operating procedures (SOPs) and test systems to support process confirmation testing activities.
• Perform nonroutine laboratory testing using approved protocols to support activities such as validations, investigations, etc.
• Author, review and revise PDU lab work instructions including, but not limited to, lab operations, calibration activities, etc.
• Prepare buffers, solutions, and test materials in accordance with SOPs and perform validity testing using specified equipment.
• Operate, set up, and perform basic troubleshooting and routine maintenance of laboratory equipment.
• Generate/review/verify test data and documentation to support batch release and ensure compliance with good documentation practices (GDP) to meet internal and external expectations.
• Support laboratory investigations, including OOS/OOT events, and generate required reports.
• Participate in resolution and identification of laboratory-related corrective and preventive actions to minimize recurrence or preventive laboratory issues.
• Maintain laboratory support readiness by ensuring adequate consumables, general 5S housekeeping, and GMP-compliant conditions.
• Assist with scheduling and prioritization of testing to meet operational timelines and production needs.
• Perform inventory and product transactions in laboratory systems, ensuring accurate data entry.
• Adhere to EHS requirements, PPE usage, and site safety procedures; proactively identify safety improvements to uphold "Safety First" culture mindset.
• Support internal and external audit readiness and participate in audit activities as required.
• Ensure personal training remains current and assist with training of other laboratory technicians.
• Collaborate effectively with cross-functional teams and communicate testing status, issues, and risks to management.
• As required, cross-train in and support Microbiology or Dosimetry laboratory related operations as PDU lab scheduling permits.

Qualifications:

Typically requires a bachelor's degree or equivalent experience and training. Typically requires a minimum of 2 years of industry related (laboratory/medical) experience (FDA regulated environment is preferred).

What you'll receive for the great work you provide:

• Full range of medical, dental, and vision plans
• Life Insurance
• Short-term and Long-term Disability
• Matching 401(k) Contributions
• Vacation and Paid Sick Time
• Tuition Reimbursement

Job Category: Quality

Is Sponsorship Available? No

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email View email address on click.appcast.io and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).