Analytical Method Transfer Specialist

For Analytical Method Transfer Specialist services in the Laboratory area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Biology, or a related scientific discipline.
• Five or more years of relevant experience in an FDA-regulated pharmaceutical, medical device, biotechnology, or combination-product laboratory environment.
• Bilingual: English & Spanish.
• Shift: Administrative and according to business needs.
• Experience in:
  • Analytical technologies such as HPLC or UPLC, GC, FTIR, UV-Visible spectrophotometry, balances, pH meters, microscopy, and associated sample-preparation equipment.
  • Transferring methods between internal sites or between a company laboratory and a contract laboratory.
  • Release, stability, assay, impurities or degradation products, residual solvents, physical testing, or cleaning-verification methods, based on project scope.
  • Supporting laboratory expansion, remediation, product transfer, audit readiness, or regulatory inspections.

The Personality Part:

• If you have a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, you might just be what we’re looking for!

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Support development of analytical method transfer plans, transfer assessments, protocols, comparative-testing strategies, acceptance criteria, and final reports.
• Coordinate transfer activities between the transferring and receiving laboratories, including schedules, samples, standards, reagents, equipment, training, and documentation readiness.
• Execute or support approved transfer testing using current procedures, specifications, worksheets, and laboratory controls.
• Confirm that required equipment is qualified and calibrated and that assigned analysts are trained before protocol execution.
• Prepare samples, standards, reagents, solutions, mobile phases, and laboratory materials accurately and in accordance with approved methods.
• Operate qualified laboratory equipment and generate, process, review, and document analytical results.
• Compile and compare results from transferring and receiving laboratories against protocol acceptance criteria.
• Support analytical method verification, qualification, validation, revalidation, troubleshooting, and lifecycle activities associated with method implementation.
• Evaluate method performance characteristics included in the approved protocol and determine whether the receiving laboratory meets established acceptance criteria.
• Document deviations and protocol exceptions occurring during method-transfer activities and support timely resolution before study closure.
• Contribute technical information to laboratory investigations, root-cause assessments, nonconformances, CAPAs, and change controls associated with transferred methods.
• Author and revise transfer protocols, reports, assessments, data summaries, procedures, worksheets, technical justifications, and supporting records.
• Maintain complete, accurate, contemporaneous, attributable, legible, and traceable laboratory records in the applicable paper or electronic systems.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!

Are you the Next Piece?