Published: August 10, 2020
- 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