Campus Pride Jobs

Overview

Follow Your Genki to FUJIFILM Diosynth Biotechnologies (FDB)

The work we do at FDB has never been more importantand 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 peoples 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 FDB call Genki

Summary:The QCStabilityCoordinator Supervisor, 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 Stability Supervisor, under general direction, will be responsible forimplementing 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. TheCoordinatorwill have visibility to method qualification to ensure timing of stability laydowns. Close attention to detail isrequiredto oversee and compile the stability testing and data, tofacilitatemeeting deadlines and milestones. Other responsibilities may include but are not limitedto:ownership of CAPAs and deviations, client meetings, attending planning meetings, communication of changes, and utilizing new software.

External US

Essential Functions:

• Assistsinpreparing QCmetricson amonthlybasis
• Performing pulls occur within the specified window
• Ensuring testing occurs within the specified window

```{=html}

``` - Assistin generating POs for external testing - Work directly with Contract laboratories to coordinate andmonitortesting 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

```{=html}

``` - Ability to work cross functionally with other Quality Control groups, Quality Assurance, Manufacturing, and Project Management toestablishtimelines - Establish GMP documentation - Review GMP documentation - Update GMP documentation - Follow all established laboratory, regulatory, safety, and environmental procedures

```{=html}

``` - Providetechnical suggestions to customers based on industry guidelines - Lead team and department meetings - Assist QC Director and QC Managers to oversee and coordinate departmental training - Conduct training for new team members and periodic training for existing team members - Ability to work cross functionally with Quality Assurance, Manufacturing, and Project Management toestablishtimelines, understand upcoming QC workload, improve quality, increase efficiency, solve problems, andprovideproduct support

```{=html}

``` - Interface with current and potential clients as well as interface with investigators during internal and external inspections - Open and track necessary change controls - Performs deviation management - Perform contract reviews - Interface with current and potential clients as well as interface with investigators during internal and external inspections.

```{=html}

``` - Supervise and lead the QC Coordinator Staff, including hiring, coaching, mentoring, and performing annual review assessments. - Open and track necessary change controls - Perform other duties as assigned.

Required Skills and Abilities:

• Must be highly organized, driven, andpossessthe skills and capability toplan aheadand stay on schedule.
• Ability to evolve and dapt tonew technologiesto include electronic planning tools and Laboratory Information Management Systems (LIMS)
• Computer skillsinMicrosoft Office and Microsoft Project
• Ability to multi-task and prioritize work assignments with little supervision
• Excellentattention to detail

```{=html}

``` - Ability to work in a team or independent setting and collaborate with employees from various departments - Excellentanalyticaland planningskills - Must have excellent organizational,written,and oral communication skills - Ability toidentifyand improve processes - Ability to oversee employees, delegate roles and responsibilities appropriately, andprovidesupport where needed

```{=html}

``` - Ability toprovideand receive constructive feedback - Possess excellentcustomerservice andinteraction skills

Working Conditions andPhysicalRequirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform theessential 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 employeeis regularly required to:

• Experience prolonged standing, some bending, stooping, and stretching.
• Use hand-eye coordination and manual dexterity sufficient tooperatea keyboard, photocopier, telephone, calculator, and other office equipment isrequired.
• Ability to sit for long periods to work on a computer.
• Attendance is mandatory.

MinimumQualifications:

• High school or GED and minimum of nine (9) years of relevant experience.
• Associates degree and minimum of seven (7) years of relevant experience.
• Bachelors degree and minimum of five (5) years of relevant experience.
• A minimum of two (2) years of previous lead or supervisory experience.

Preferred Qualifications:

• Bachelorsdegree ina scientificdiscipline
• PMPCertificate
• Analytical background
• Client relations background

```{=html}

``` - Lean Six Sigma training or similar process improvement training

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[FDBTHR@fujifilm.com]{rel="noopener" target="_blank"}or call 979-431-3500.