Lead QC Associate II

Durham County, NC - USA

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Department:

Quality Control

Job Summary

Position Overview

The Lead QC Associate II role in Quality Control Microbiology is crucial for overseeing and guiding the critical operational functions of the QC Microbiology laboratory. This position holds the responsibility for conducting microbiological assays as well as for effectively training junior analysts in these areas. The incumbent will operate largely autonomously ensuring technical issues are promptly escalated to laboratory management. Overtime and temporary shift changes will be required to support programs that have samples with short testing windows (e.g. bioburden 12-hours).

Company Overview

At FUJIFILM Biotechnologies were leading the charge in advancing tomorrows medicines. If you want to be a part of life-impacting projects alongside todays most innovative biopharmaceutical companies FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site we thrive on collaboration creativity and purpose. Whether your expertise lies in research manufacturing or production youll find a home here where your efforts directly improve patients lives. Together lets shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP) North Carolina our site is at the heart of a booming biotech hub surrounded by top universities vibrant communities and various outdoor opportunities.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

Major Accountabilities:

Performs complex microbiological testing per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches. Testing may include but is not limited to Bioburden Endotoxin Culture Purity and Microbial Identifications.
Reviews technical data authors routine and periodic laboratory reports (e.g. EM trend reports) and contributes to technical documentation and assessments.
Ensures laboratory maintains inspection readiness data integrity and Current Good Manufacturing Practice (CGMP) compliance.
Assists management with technical services such as initiating events (e.g. deviations and non-conformances) within quality systems.
Leads laboratory deviations and investigations.
Identifies and solves problems while informing and consulting with area management.
Participates in project developments from concept through execution ensuring alignment with organizational goals.
Partners with laboratory management in scheduling of daily weekly and non-routine testing and tasks.
Provides technical guidance and mentorship to junior analysts.
Participate or lead laboratory equipment qualification or validation.
Troubleshoots assay and method issues with the support of laboratory management.
Troubleshoots laboratory equipment when issues arise.
Performs other duties as assigned.

Knowledge Skills or Abilities:

Strong working knowledge of aseptic techniques and behaviors
Effective communication both written and verbal
Superior technical writing and problem-solving skills
Ability to aseptically gown into classified manufacturing spaces
Ability to complete work both independently with minimal supervision
Ability to prioritize and organize work to deliver assignments according to established schedules and deadlines
Ability to effectively collaborate with coworkers and internal clients
In-depth understanding and working knowledge of United States Pharmacopeia and European Pharmacopeia
Ability to support audit readiness for the laboratory
Willingness to learn and incorporate lean lab and six sigma principles into the work environment
Ability to manage and complete tasks according to a structured plan
Expertise with data management systems such as TrackWise LIMS and capability to learn basic use and navigation within the systems
Must be flexible to support 24/7 manufacturing facility

Minimum Education Requirements

High School Diploma and at least 8 years of laboratory experience in a cGMP environment; or
Associates degree in Life Science Pharmaceutical or related field with at least 6 years of laboratory experience in a cGMP environment; or
Bachelors degree in Life Science or Biology with at least 4 years of experience in a cGMP environment

Preferred Experience

BioWork Certificate

Physical Requirements:

Will work in environment which may necessitate repiratory protection
Ability to discern audible cues
Ability to inspect or perform a task with 20/20 corrected visition visual acuity including distinguishing color
Ability to asend or descend ladders scaffolding ramps etc.
Ability to stand for prolonged periods of time (240 minutes)
Ability to sit for prolonged periods of time (240 minutes)
Ablity to conduct activities using repetitive motions that include wrists hands and/or fingers
Ability to conduct work that includes moving objects up to 33lbs
Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions.
Will work in warm/cold environments (0-100F range)

*#LI-Onsite

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 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 committedto 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 ().

Required Experience:

Position OverviewThe Lead QC Associate II role in Quality Control Microbiology is crucial for overseeing and guiding the critical operational functions of the QC Microbiology laboratory. This position holds the responsibility for conducting microbiological assays as well as for effectively training ...