The QC Lead Associate III position is a first shift (Monday-Friday) lead function, assisting laboratory management with the coordination and assignment of activities within the assigned shift. The incumbent, in addition of management support will author and/or execute complex protocols, Method Transfer and test plans. The individual will also be responsible to author and/or lead QC Microbiology investigations and represent the QC microbiology laboratory in cross-functional investigations. The position will also support routine testing by testing samples, reviewing data, and delivering RFT, on-time results to the various QC customers.
The QC Lead Associate III position is a first shift (Monday-Friday 7 am-7p) lead function, assisting laboratory management with the coordination and assignment of activities within the assigned shift. The incumbent, in addition of management support will author and/or execute complex protocols, Method Transfer and test plans. The individual will also be responsible to author and/or lead QC Microbiology investigations and represent the QC microbiology laboratory in cross-functional investigations. The position will also support routine testing by testing samples, reviewing data, and delivering RFT, on-time results to the various QC customers.
The individual has demonstrated analytical capability and is able to apply knowledge and experience to the tasks of lab coordination, work scheduling, investigations, and technical writing. The position coordinates with analysts and area management to assure shift resources are available and testing is completed per procedure. The individual may review SOPs, protocols, summary reports or forms to assure accuracy and suitability for routine or ad hoc laboratory testing. The individual may prepare protocols and procedures to facilitate project or technical transfer activities.
Other responsibilities include, but are not limited to:
Informs/consults with management regarding resource conflicts.
Works with department management to assure priorities and activities such as stability testing, housekeeping, lab supply inventory, etc. are maintained according to schedule.
May be assigned to specific disciplines, but will support all necessary laboratory and assay functions, including housekeeping, safety, logbook use and maintenance, equipment uses and maintenance, method execution, and data review.
Applies lean lab and six sigma principles to daily activity
May review data and create summary reports; assures data is delivered to customers as required
May generate reports and recommendations; can identify statistically significant and impactful events
May lead and/or coordinate method transfers, qualifications, and validations
Track and coordinates timeliness of laboratory investigations, deviations and corrective actions
May act as a coach to new or junior analysts
Coordinates or assists in resolving laboratory or sample-related issues
Management Support activities- 70%
Laboratory analysis- 20%
Other activities- 10%
Minimum Education Requirements
•
BS/BA in science, preferably in biology, microbiology, pharmaceutical sciences, or related technical field
Desired Experience
•
6+ years related laboratory experience (4 years required with relevant MS degree)
Specific Skills and Competencies
•
Capable of high through-put and high quality, RFT work
•
Certified or capable of timely certification for Yellow Belt
•
Demonstrated subject matter expert in several QC Microbiology disciplines
•
Proficient technical writing skills
•
Able to make informed and timely decisions independently
•
Can manage multiple assignments in timely and effective manner
•
Effective communication skills with colleagues both within and outside of the department
Capable of recognizing process gaps and implementing improvements
Leadership traits that build and foster trust, respect, cooperation, and collaboration across the organization.
Company Overview
We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At FUJIFILM Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.
Job DescriptionThe QC Lead Associate III position is a first shift (Monday-Friday) lead function, assisting laboratory management with the coordination and assignment of activities within the assigned shift. The incumbent, in addition of management support will author and/or execute complex protocols, Method Transfer and test plans. The individual will also be responsible to author and/or lead QC Microbiology investigations and represent the QC microbiology laboratory in cross-functional investigations. The position will also support routine testing by testing samples, reviewing data, and delivering RFT, on-time results to the various QC customers.
The QC Lead Associate III position is a first shift (Monday-Friday 7 am-7p) lead function, assisting laboratory management with the coordination and assignment of activities within the assigned shift. The incumbent, in addition of management support will author and/or execute complex protocols, Method Transfer and test plans. The individual will also be responsible to author and/or lead QC Microbiology investigations and represent the QC microbiology laboratory in cross-functional investigations. The position will also support routine testing by testing samples, reviewing data, and delivering RFT, on-time results to the various QC customers.
The individual has demonstrated analytical capability and is able to apply knowledge and experience to the tasks of lab coordination, work scheduling, investigations, and technical writing. The position coordinates with analysts and area management to assure shift resources are available and testing is completed per procedure. The individual may review SOPs, protocols, summary reports or forms to assure accuracy and suitability for routine or ad hoc laboratory testing. The individual may prepare protocols and procedures to facilitate project or technical transfer activities.
Other responsibilities include, but are not limited to:
Informs/consults with management regarding resource conflicts.
Works with department management to assure priorities and activities such as stability testing, housekeeping, lab supply inventory, etc. are maintained according to schedule.
May be assigned to specific disciplines, but will support all necessary laboratory and assay functions, including housekeeping, safety, logbook use and maintenance, equipment uses and maintenance, method execution, and data review.
Applies lean lab and six sigma principles to daily activity
May review data and create summary reports; assures data is delivered to customers as required
May generate reports and recommendations; can identify statistically significant and impactful events
May lead and/or coordinate method transfers, qualifications, and validations
Track and coordinates timeliness of laboratory investigations, deviations and corrective actions
May act as a coach to new or junior analysts
Coordinates or assists in resolving laboratory or sample-related issues
Management Support activities- 70%
Laboratory analysis- 20%
Other activities- 10%
Minimum Education Requirements
•
BS/BA in science, preferably in biology, microbiology, pharmaceutical sciences, or related technical field
Desired Experience
•
6+ years related laboratory experience (4 years required with relevant MS degree)
Specific Skills and Competencies
•
Capable of high through-put and high quality, RFT work
•
Certified or capable of timely certification for Yellow Belt
•
Demonstrated subject matter expert in several QC Microbiology disciplines
•
Proficient technical writing skills
•
Able to make informed and timely decisions independently
•
Can manage multiple assignments in timely and effective manner
•
Effective communication skills with colleagues both within and outside of the department
Capable of recognizing process gaps and implementing improvements
Leadership traits that build and foster trust, respect, cooperation, and collaboration across the organization.
EEO Information
Fujifilm is committed to 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 InformationIf you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (HR_FDBU@fujifilm.com).
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