Analytical Technical Services Specialist - Combination Product
About the Job
Accountable for transferring and optimization of combination product analytical methodology including new emerging technology. Also accountable for the evaluation and closing of QC and ATS Laboratory investigations (Quality Events), Change Controls, Corrective Action Preventive Actions (CAPA’s) according to BMS procedures and policies to ensure that procedures in the laboratory comply with BMS policies. This position must comply with all security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function. Designs, evaluates, and executes Analytical Method Transfer protocols for Combination Products. Executes technical transfer and startup of new and existing Combination Products methods into the Quality Control ensuring that critical parameters are clearly communicated to the receiving site. Designs, executes and evaluates method development protocols to ascertain the required degree of validation for new and existing methods guaranteeing implementation of a feasible, efficient, rugged, and robust method; and generates method development reports as required. Coordinates analytical transfers to / from the BMS Manatí site in a timeless manner and; performs and / or oversees combination products analytical method validation if necessary. Originates and implements QC / ATS Laboratory changes controls following BMS procedures and policies ensuring the accuracy of the information and closing within the established time frame. Originates and implements corrective and preventive actions following BMS procedures and policies and closing them within the established time frame. Conducts complex Laboratory Investigations ensuring the identification of the root cause and corrective and preventive action to prevent re-occurrence. Recommends and makes changes to documents (e.g. SOP’s, protocols, Testing Standard, methods, monographs, etc.) and ensures that these documents are aligned with the cGMP practice and BMS policies and; verifies and ensures consistency with other sites procedures and/or specifications. Provides training to new members on approved methods and procedures following applicable training SOP. Reviews new drug product fillings to ensure are in accordance with current practices in the QC/ATS laboratory. Reviews new products specification ensuring the generated data at site level, comply with the proposed specifications. Leads and performs special projects. Determines requirements for documentation, materials, trainings and equipment modifications within the laboratories during the new combination product introduction process. Conducts internal audits in the ATS laboratory to ensure that the areas are in compliance with BMS procedures and policies. Generates protocols, reports, technical assessments and technical memos.Bachelor’s Degree in Natural Sciences or Engineering. Minimum of five (5) years of experience in a Quality Assurance/Quality Control/Analytical Laboratory within the Medical Device or Pharmaceutical industry. Broad knowledge of cGMP governmental regulations and guidelines, and the ability to interpret and apply. Ability to communicate effectively with wide range of personnel, written and verbal. Strong technical writing and interpretation skills related to investigations and Regulatory Filings. Ability to create and organize cGMP systems and procedures based on regulatory compliance requirements. In depth analytical thinking, statistical analysis, problem solving and technical investigation skills. Knowledge and experience of computer and appropriate software packages. (e.g., word processing, spreadsheets, Empower, communications like e-mail, LIMS, etc.). Knowledge to collect and document data and/or other information (e.g. significant figures, rounding off rules, degradation products reporting, etc.). Knowledge of computers applications (Microsoft Word, Project, Excel, Power Point, Minitab). Excellent interpersonal skills and team work oriented. Excellent communications skills in Spanish/English. Knowledge of Good Documentation Practices and statistical tools. Willing to work irregular hours, rotating shifts, weekends and holidays.