Overview
Quality Manager Jobs in Louisville, KY at Calhoun Construction Services
Position Overview:
Summary: The QC Stability Coordinator II will construct, maintain, and oversee the Quality Control Testing of Stability programs to include developing a schedule of pull dates, overseeing testing of each pull, and generating summaries from the data.
The Quality Control Coordinator II, under general direction, will be responsible for implementing a Quality Control Stability Program that will encompass the needs of the client for each program. The position will require frequent communication with the Chemistry, Cell Biology, Microbiology, and Quality Assurance groups to coordinate execution of testing, deviation management, and issuance of deliverables. The Coordinator will have visibility to method qualification to ensure timing of stability laydowns. Close attention to detail is required to oversee and compile the stability testing and data, to facilitate meeting deadlines and milestones. Other responsibilities may include but are not limited to: ownership of CAPA’s and deviations, client meetings, attending planning meetings, communication of changes, and utilizing new software.
Company Overview:
The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive – what FUJIFILM Diosynth Biotechnologies call Genki.
College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas’ population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.
Job Description:
Essential Functions:
Assists in preparing QC metrics on a monthly basis
Performing pulls occur within the specified window
Ensuring testing occurs within the specified window
Assist in generating POs for external testing
Work directly with Contract laboratories to coordinate and monitor testing and release schedules
Work directly with customers to update and confirm schedules and deadlines
Attend daily briefings and update as needed
Assist QC Director and QC Managers
Ability to work cross functionally with other Quality Control groups, Quality Assurance, Manufacturing, and Project Management to establish timelines
Establish GMP documentation
Review GMP documentation
Update GMP documentation
Follow all established laboratory, regulatory, safety, and environmental procedures
Maintain and execute a minimum of 8 stability protocols
Provide technical suggestions to customers based on industry guidelines
Follow all established laboratory, regulatory, safety, and environmental procedures
Perform other duties as assigned
Required Skills & Abilities:
Must be highly organized, driven, and possess the skills and capability to plan ahead and stay on schedule
Ability to evolve and adapt to new technologies to include electronic planning tools and Laboratory Information Management Systems (LIMS)
Understanding of ICH guidelines for stability testingUnderstanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP).
Extensive knowledge of stability testing protocols, methodologies, and regulatory requirements
Computer skills in Microsoft Office and Microsoft Project
Ability to multi-task and prioritize work assignments with little supervision
Excellent attention to detail
Ability to work in a team or independent setting and collaborate with employees from various departments
Excellent analytical and planning skills
Must have excellent organizational, written and oral communication skills
Minimum Qualifications:
Bachelor’s degree in chemistry, Biochemistry, Biology, Biotechnology, Microbiology or similar education and minimum of 2 years’ experience between coordinator/management position and 1 year in a GxP setting; OR
Master’s degree and minimum of 1 year experience between coordinator/management position and 1 year in a GxP setting.
Preferred Qualifications:
PMP Certificate
Knowledge and experience with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Analytical background
Client relations background
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
Experience prolonged standing, some bending, stooping, and stretching
Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required
Ability to sit for long periods to work on a computer
Attendance is mandatory
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.
If an accommodation to the application process is needed, please e-mail [email protected] or call 979-431-3500.
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
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 Information:
If 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 ([email protected] or (979) 431-3500).
Title: Quality Manager
Company: Calhoun Construction Services
Location: Louisville, KY
