Senior Manager Quality Control Microbiology
Senior Manager Quality Control Microbiology
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$ 150000 - 175000
1 Vacancy
Job Description
Position Overview
The Sr. Manager Quality Control (QC) Microbiology at Fujifilm Diosynth Biotechnologies California (FDBC) requires both leadership technical and business expertise. From a leadership perspective the selected individual will need to lead develop and motivate staff. This requires a selfmotivated flexible and creative leader able to prioritize multitask and work in a fastpaced & demanding environment. From a technical perspective the selected individual will directly oversee QC Microbiology activities and deliverables to provide systems and processes to enable QC to complete department objectives. The Sr. Manager is responsible for ownership of FDBC Environmental Monitoring Program and proactively identifies and implements industry standard methodologies for QC Microbiology. In addition role model company core values of trust delighting our customers Gemba and Genki.
Company Overview
Join us! FUJIFILM Diosynth Biotechnologies is advancing tomorrows medicine impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers driven by an innate desire to better ourselves our families our workplace our company our community and the world at large.
Job Description
Job Type: Full Time
City: Thousand Oaks (Los Angeles)
Reports to: Sr Director Quality Control
Travel: Limited Travel (up to 10.
Physical Requirements: Subject to extended periods of sitting.
Primary Responsibilities:
- Lead and develop a team of individuals in alignment with departments objectives.
- Manage QC activities relating to new business initiatives strategic planning data management and coordination of QC microbiology deliverables.
- QC Point of Contact for Environmental Monitoring Program at FDBC.
- Manage the Environmental Monitoring Program and Aseptic Gowning Qualification Program providing oversight in the development and implementation of standards methods procedures and sampling.
- Provide guidance to the continuous improvement of Environmental Monitoring trend analysis data integrity assurance practices for lab information and on the floor laboratory oversight support.
- Support cGMP manufacture testing and supply of highquality cell therapy products.
- Develop phaseappropriate QC Microbiology capabilities business processes and procedures.
- Coordinate of disinfection effectiveness studies.
- Ensure adequate inventory of laboratory media and supplies required to perform testing.
- Oversees and supports team that investigates deviations that occur in Quality Control areas.
- Supports laboratory investigations OOS root cause analysis and corrective action/preventive action implementation
- Review and approve documents required to support QC Microbiology process documents.
- Coordination of strategic and operational activities within QC including project support coordination collation of information reporting and data analysis.
- Facilitate effective communication across internal departments.
- Works closely with team members to provide effective solutions to support business and quality objectives.
- Defines and analyzes key performance metrics to drive continuous improvement across QC Microbiology.
- Support regulatory inspections/audits.
Qualifications:
Position Requirements:
- Mastery knowledge of aseptic techniques and aseptic gowning
- Mastery knowledge in analytical or microbiological methods and respective instrumentation
- Mastery knowledge of document management and lifecycle
- Mastery knowledge of quality systems and their interconnections
- Mastery knowledge of how to control request receive and/or distribute product/samples
- Mastery knowledge of product testing data analysis and reporting
- Advanced knowledge of sampling plan lifecycle and inventory management
- Advanced knowledge of computer systems (e.g. Word Excel LIMS)
- Advanced knowledge of executing methods (e.g. casual factor analysis) for qualification transfers and validation
- Advanced knowledge of regulations and inspection/audit readiness
- Advanced knowledge of QMS (CAPA deviation change control laboratory investigation)
- Experience in smartsheet statistical analysis and/or statistical analysis software (i.e. JMP) is a plus.
- Expert understanding in verbal and written communication customerservice oriented
- Expert understanding in problem solving and critical thinking
- Expert understanding in project management teamwork & collaboration
- Expert understanding in decision making
Education and Professional Experience:
- 5 years of team management experience
- Bachelor of Science (B.Sc. with 10 years of experience or an equivalent combination of education; or Master of Science (M.Sc. with 7 years of experience; or PhD in Science with 5 years of experience
SALARY AND BENEFITS:
- $150000 to $175000 depending on experience
- Medical Dental and Vision
- Life Insurance
- 401k
- Paid Time Off
To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM viaemail the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.
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EEO Information
Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.
ADA Information
If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().
Required Experience:
Senior Manager
Employment Type
Unclear
