Grifols Shared Services North America, Inc QC Microbiology Manager in San Diego, California
Grifols is a global healthcare company whose mission is to improve the health and well being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
The QC Microbiology Manager will direct the day to day to day operations of one of the Grifols Diagnostic Solutions Quality Control Laboratories Microbiology testing function which consist of: Method Validation, Stability, Environmental Monitoring, testing and release of manufactured reagents and Raw Materials (RM), QC Microbial and QC Equipment/eSystems programs. The Manager will work with Engineering, Validation and Manufacturing Sciences groups to drive new method qualifications, and schedule any QC Micro testing. Responsible for directing the work of other QC supervisors and associates, as well as examine and define QC processes that can be streamlined and improved within the QC Microbiology Team.
Primary responsibilities for role:
Direct the day to day operation of one of the QC Micro laboratories. Manage a staff of approximately 5-8 individuals responsible for Method Validation, Environmental Monitoring, Bioburden testing, Growth Promotion, Other Microbiological assays, Equipment/eSystems as well as in-process, final product (antigens), stability, reference qualification, in-process, cleaning validation and product development (MS&T) testing functions. The Manager will also be responsible for investigating OOS/OOT/OOE deviations in their designated functional area, ensuring that DRs and CAPAs are submitted to QA for closure on time.
Owns the procedures that govern their assigned functional area and ensures that all documents are approved and in alignment with the applicable Grifols Quality Standards
Ensure that their designated QC laboratory provide on time testing
Oversee laboratory investigations in their assigned area
Execute OE projects such as 5S, Value Stream Mapping (VSM), “Role Cards”, “Level and Flow”, “Standard” work for their assigned QC processes
Select, train and develop staff so that they realize their full potential and work in conformance to company policies relating to environmental protection, health and safety at work.
Work with Site Environmental Health & Safety (EH&S) representatives to ensure that their assigned QC laboratory adheres to Grifols EH&S standards, requirements and best practices
Timely release testing for all raw materials and labeled reagents
Timely execution of routine and manufacturing environmental monitoring
Completion of stability testing requiring microbiological techniques, submitting data review in a intervals and reports within the required times
Completion of Method Validations and Method Validation evaluations
Completion of onboarding of new equipment
Investigation and closure of DRs and closure of CAPAs within the required time
OOS and QC related DRs defended to regulatory agencies during product review or site inspections.
The number and severity of GMP issues identified during internal and external audits related to their assigned laboratory functions.
Efficiency of assigned laboratory operations.
No safety incidents or HSE related observations.
Knowledge, Skills, and Abilities:
Microbiological methods such as Microbial Limits Test (bioburden), Sterility, Endotoxin, TOC, Microbial Identification, Growth Promotion, PET testing, Disinfectant Qualifications.
Environmental/Utility/facility Monitoring programs, with knowledge of area classifications and required environmental monitoring as well as manufacturing water systems and required quality testing requirements
Analytical/Microbiological Method Validation, assay development/transfer and assay trouble shooting
Bachelor’s degree in Microbiology with 6 years of direct experience in QC Microbiology or MS/PhD degree in science with 4 plus years.
At least 6 years experience in a regulated GMP testing laboratory with 4 years in a supervisor level position.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home
Req ID: 65307
Type: Regular Full-Time
Job Category: Quality