Director of Microbiology and Aseptic Process

Published: August 10, 2020
North Region, Puerto Rico, Puerto Rico
Job Type
Job Code
Years of Experience
Commensurate with candidate experience.
Bachelor’s Degree
Ilia Cordero
Contact Email



  • Provides technical leadership and guidance to the site QC Microbiology and Aseptic Processes staff to insure timely completion of goals and objectives.
  • Prioritizes projects and determines resource constraints when necessary.
  • Develops and implements goals, objectives and mechanisms to ensure the optimum operational, financial and regulatory performance of the microbiological testing laboratory consistent with departmental and site strategies, SOPs and WWQ&C policies.
  • Ensures that site Microbiology and Aseptic Processes staff receives training in appropriate procedures and protocols, including safety, cGMP training, etc. Overall, assures compliance with all accepted laboratory and safety procedures.
  • Oversights microbiological testing of raw materials, finished products, USP water and cleaning samples. Supports validation activities of the site ensuring microbiological testing of validation samples is performed as required period.
  • Coordinates administrative activities, ex. HR issues, budget, hiring, performance partnerships, etc.
  • Ensures that the Microbiology and Aseptic Processes personnel have the required materials, equipment and tools to support site operations.
  • Serve as a key liaison with the Microbiology and Compliance Network.
  • Participates on project teams to ensure that laboratories representation is provided on technical issues.
  • Assures that data and reports generated by direct reports are consistent and accurate.
  • Interfaces with other groups in GPS on project issues to build collaboration and harmonization within the development and manufacturing network at the company.
  • Ensures that all activities are performed in compliance with federal and local regulatory agencies (e.g., OSHA, EPA, FDA, etc.).
  • Ensures site GMP required procedures are in alignment and compliance with the Corporate Compliance and WWQ&C Headquarters Policies and Directives.
  • Maintains a safe work environment for Microbiological laboratories and Aseptic Processes personnel.
  • Interacts and supports inspections and regulatory submissions with regards to Microbiology and Aseptic Processes matters.
  • Ensures that deviations from procedures and specifications are investigated, resolved and documented, that corrective / preventive actions are identified and implemented to avoid the occurrence / recurrence of deviations and that no materials are released before the completion of the investigation.
  • Notifies the appropriate levels of management within Quality Operations Senior Management of significant quality issues in a timely fashion.
  • Ensures the effectiveness of the environment review committee (ERC) for the review and adherence of conference of corrective and preventive actions associated to the sterile operations environment controls.
  • Assures that the Microbiology and Aseptic Processes equipment and personnel are formally qualified before release testing of products/materials is performed.
  • accuracy and completion of Annual Product Quality Review Report elements pertaining the laboratory inputs as established in products / systems schedule.
  • Approves or reject procedures affecting drug products, raw material, and USP water or packaging components


  • BS in Microbiology, Biology or Equivalent scientific field.
  • Ten (10) years of progressive managerial experience within the quality operations function of a pharmaceutical/health care industry and regulatory agencies, with experience in chemical analytical and/or microbiology laboratories.
  • Excellent communication skills in both English and Spanish.
  • Knowledge in microbiological instrumentation and techniques and aseptic processes.
  • Strong leadership skills.
  • Excellent verbal, written and presentation skills and can deal effectively with all levels of management.
  • Must be innovative and creative and utilize all available resources.
  • Proficient in cGMP’s and FDA regulations and requirements.
  • Excellent interpersonal skills.
  • Working knowledge in PC’s and electronic tools.
  • A systematic decision maker, assuring decisions are fact based and clearly documented
  • Planning skills
  • Excellent analytical and problem-solving skills
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