Quality Control Specialist Operations

The QC Operations Specialist at Fujifilm Diosynth Biotechnologies, California (FDBC) supports Quality Control (QC) activities relating to new business initiatives, strategic planning, data management, and coordination of QC Operations deliverables. This role assists and supports the Director, QC Operations to manage and monitor QC deliverables through the establishment of routine reporting and robust project management framework and business improvement support tools throughout QC. The position owns method monitoring program to monitor and trend data from QC Analytical Methods. The position supports on-site activities related to sample management.

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.

Job Type: Full Time (on-site)

City: Thousand Oaks

Reports to: Director, Quality Control

Travel: Limited Travel (up to 10%).

Position Summary
The QC Operations Specialist at Fujifilm Diosynth Biotechnologies, California (FDBC) supports Quality Control (QC) activities relating to new business initiatives, strategic planning, data management, and coordination of QC Operations deliverables. This role assists and supports the Director, QC Operations to manage and monitor QC deliverables through the establishment of routine reporting and robust project management framework and business improvement support tools throughout QC. The position owns method monitoring program to monitor and trend data from QC Analytical Methods. The position supports on-site activities related to sample management.

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

• Point of contact for Lot status of QC Certificate of Analysis.
• Attends work center team meetings and provides project updates.
• Develop and implement procedures for effective data management.
• Performs document management tasks for forms, procedures, and work instructions.
• Partner with testing stakeholders, as required, to ensure appropriate and timely determination of potential issues impacting testing completion.
• Facilitate effective communication across internal departments by trending and reporting data.
• Work with QC management to continually develop data management strategies.
• Assist in the coordination of strategic and operational activities within QC including project support, coordination, collation of information, reporting, and data analysis.
• Defines and analyzes key performance metrics to drive continuous improvement across QC operations.
• Execute on-site sample management activities, which include control, receipt, and distribution of product, intermediates, raw materials samples, sample retention, reference samples, and stability samples.
• Performs document management tasks for writing reports, procedures, and work instructions.
• Provide support and assistance to the organization to report QC Quality metrics and key performance indicators.
• Works closely with team members to provide effective solutions to support business and quality objectives.
• Support regulatory inspections/audits.
• Own the method monitoring program at FDBC and performs statistical analysis of method data.
• Regularly monitor and evaluate information and data systems that could affect analytical results.
• Lead and facilitate periodic tactical meetings with associated testing stakeholders to track testing status.

SKILLS AND ABILITIES

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

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.

• Life Insurance
• Paid Time Off
• $100,000 to $115,000 per year, depending on experience.
• 401k
• Medical, Dental, Vision