The QC Microbiology Specialist at Fujifilm Diosynth Biotechnologies, California (FDBC) supports Quality Control Microbiology (QCM) activities relating to training, new business initiatives, strategic planning, data management, and coordination of QCM Operations deliverables. This role assists and supports the QC Microbiology team in managing and monitoring QCM deliverables through the establishment of routine reporting and robust project management framework and business improvement support tools. The position owns Environmental Monitoring (EM) trending program to monitor and trend data from Environmental Monitoring (EM).

The Specialist position will interact regularly with QC, Quality Assurance, and Manufacturing. In addition to external Quality representatives supporting client requests and/or notifications. Individuals in this role are customer service-oriented, proficient in verbal and written communication, time management, and demonstrate expert understanding in critical thinking and problem solving. In addition, role model company core values of trust, delighting our customers, Gemba, and Genki.

Quality Control Microbiology Specialist

Job Type: Full Time (on-site)

City: Thousand Oaks

Reports to: Director, Quality Control

Travel: Limited Travel (up to 10%)

Shift: Mon-Fri (8 hours per day). Will periodically support weekends and holidays

Position Summary

The QC Microbiology Specialist at Fujifilm Diosynth Biotechnologies, California (FDBC) supports Quality Control Microbiology (QCM) activities relating to training, new business initiatives, strategic planning, data management, and coordination of QCM Operations deliverables. This role assists and supports the QC Microbiology team in managing and monitoring QCM deliverables through the establishment of routine reporting and robust project management framework and business improvement support tools. The position owns Environmental Monitoring (EM) trending program to monitor and trend data from Environmental Monitoring (EM).

The Specialist position will interact regularly with QC, Quality Assurance, and Manufacturing. In addition to external Quality representatives supporting client requests and/or notifications. Individuals in this role are customer service-oriented, proficient in verbal and written communication, time management, and demonstrate expert understanding in critical thinking and problem solving. In addition, role model company core values of trust, delighting our customers, Gemba, and Genki.

Primary Responsibilities:

• Assists in the coordination of strategic and operational activities within QC including project support, coordination, collation of information, reporting, and data analysis.
• Attends work center team meetings and provides project updates.
• Provides support and assistance to the organization to report QCM Quality metrics and key performance indicators.
• Leads and facilitates Deviation investigations, CAPAs and Change Controls
• Independently writes technical reports as needed.
• Develops and implements procedures for effective data management.
• Regularly monitors and evaluates information and data systems that could affect EM trending Results.
• Owns the method or EM monitoring program at FDBC and performs statistical analysis of EM data.
• Works with QCM management to continually develop data management strategies.
• Point of contact for lot specific EM Data Summaries and Media Simulations
• Performs document management including review of tasks for forms, procedures, and work instructions.
• Facilitates effective communication across internal departments by trending and reporting data.
• 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
• Performs document management tasks for writing reports, procedures, and work instructions.
• Oversight of training in the QC Microbiology department
• Support regulatory inspections/audits.
• Perform other duties as assigned by manager.

Skills and Abilities:

• A minimum of 3 years’ experience working within a GxP regulated environment preferred.
• Working knowledge of document management and lifecycle.
• Working knowledge of quality systems and their interconnections.
• Basic knowledge of product testing, data analysis, and reporting.
• Advanced knowledge of computer systems (e.g. Word, Excel, LIMS). Experience with Smartsheet is a plus.
• Advanced knowledge in statistical analysis, and/or statistical analysis software (i.e., JMP)
• Working knowledge of regulations and inspection/audit readiness.
• Advanced knowledge in Quality Management Systems (Deviation, CAPA, and/or Change Control)
• Strong communication skills (written and verbal) with demonstrated experience on Presenting EM Data and other technical reports to multi-departments Senior Management
• Self-motivated, flexible & creative, able to prioritize, multi-task and work in a fast-paced & demanding environment.

Physical Requirements:

• Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is performed in an office environment.

EDUCATION AND PROFESSIONAL EXPERIENCE

• Bachelor’s degree in Science with 5+ years of experience or an equivalent combination of education and experience; OR
• Master of Science degree with 3+ years of experience; OR
• PhD in Science with 0-3 years of experience

Salary and Benefits:

• $100k to $115k per year, depending on experience
• Medical, Dental and Vision
• Life Insurance
• 401k
• Paid Time Off

Join us!  FDB is advancing tomorrow’s 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.

 FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.

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 via-email, 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.