Director of Microbiology and Aseptic Process

Published: August 10, 2020
Location
North Region, Puerto Rico, Puerto Rico
Job Type
Job Code
36911
Years of Experience
10
Salary
Commensurate with candidate experience.
Travel
No
Education
Bachelor’s Degree
Contact
Ilia Cordero
Contact Email
icordero@careersincpr.com

Description

Responsibilities:

  • 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

Requirements

  • 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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