Quality Control Supervisor Microbiology - Fujifilm

Overview

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.  The QC Supervisor, Microbiology provides day to day oversight of routine and non-routine microbiological activities both in the laboratory and inside the classified Manufacturing Environment. This includes providing oversight on the execution of the environmental monitoring program, gowning qualification, and personnel monitoring program, compressed gases testing program and incoming testing of media.

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 QC Supervisor, Microbiology

 The QC Supervisor, Microbiology provides day to day oversight of routine and non-routine microbiological activities both in the laboratory and inside the classified Manufacturing Environment. This includes providing oversight on the execution of the environmental monitoring program, gowning qualification, and personnel monitoring program, compressed gases testing program and incoming testing of media.

Reports to: Director, QC Microbiology

Location: Thousand Oaks, CA

Travel: Less than 10%

Shift: This role will support a 4 day/10-hour work schedule. Either Sunday – Wed or Wed Saturday shifts or a split shift, Mon, Tue, Thu, Fri. Other work shift can be assigned.

Primary Responsibilities

• Provide oversight for environmental monitoring support for aseptic processes
• Supervision of aseptic gowning training and qualification program
• Ensure that lab and environmental monitoring activities are conducted according to safety guidelines and policies.
• Prepare and review Environmental Monitoring Reports and Aseptic Operator Qualification reports.
• Revise and review SOPs, qualification/validation protocols and reports.
• Review quality documentation from the environmental monitoring program, utility monitoring and other microbiology laboratory methods.
• Review and propose changes to process, procedures and methods as needed.
• Conduct or support EM excursions investigations as Subject Matter Expert (SME)
• Maintain quality and quantity of departmental work through initial and continued training and oversight of lab staff; propose additional or customized training to lab management according to need.
• Responsible for scheduling of EM testing and other Microbiology testing.
• Responsible for test data review.
• Ensure equipment and materials availability.
• Provides support needed for investigations e.g., malfunction of equipment, contamination investigation, EM investigations.
• Perform administrative duties such as approval of time documentation, performance reviews, disciplinary actions as needed.
• Participates in regulatory or client inspections. Responsible for professional development goal setting and performance review of staff.
• Provide information in support of department budget.
• Determine the number of personnel required to support the overall workload and hire new personnel as needed
• Contribute to departmental strategy and provide input on lab requirements and improvements.

Note: The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

Physical Requirements

• Subject to extended periods of sitting and/or standing in a laboratory or classified environment.
• Ability to lift 50 lbs. and to work in controlled and classified space required.
• Ability to reach above the shoulder and bend to be able to don gown for aseptic environment.

Education and Professional Experience

• 0-2 years of team management experience
• Bachelor of Science (B.Sc.) with 5+ years of experience or an equivalent combination of education; or
• Master of Science (M.Sc.) with 3+ years of experience; or
• PhD in Science with 0-3 years of experience
• BS/MS degree in a scientific discipline preferred in analytical chemistry, microbiology, or related field.
• Experience in managing a cGMP quality control laboratory highly desirable and
• Experience working in a matrix managed team environment and an ability to work effectively with all departments within the company.

Position Requirements

• Must be well versed in various microbiological techniques.
• Good organizational and planning skills and ability to work efficiently.
• Ability to be flexible with schedule and work overtime as needed.
• Must be highly organized, detail oriented and able to manage multiple projects.
• Strong written and verbal communication, organization, and prioritization skills
• Ability to handle multiple priorities in a project driven environment.
• Ability to maintain detailed and accurate records.
• Team player with good interpersonal skills
• Strong commitment to teamwork, proven leadership skills, independence, and initiative
• Proficient in Microsoft Office - Word, Excel, PowerPoint
• Comprehensive knowledge of pharmaceutical GLPs and GMPs
• Comprehensive knowledge of laboratory techniques and safety precautions
• Experience with LIMS software applications is highly desirable

Salary and Benefits:

• $50 to $60 per hour, 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.