Associate 2, QC Microbiology (Sunday- Wednesday 2pm - 12am)

Durham County, NC - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Department:

Quality Control

Job Summary

Position Overview

The Associate 2 Quality Control (QC) Microbiology is responsible for performing routine microbiological testing of clean utility environmental monitoring and manufacturing batch samples. This role performs routine laboratory testing and support activities and actively participates in continuous improvement initiatives. 2nd shift.

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

Provides facility support through the collection and testing of site clean utilities (e.g. water stem and compressed gases)
Performs microbiological testing (e.g. Bioburden Endotoxin and Growth Promotion) per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches
Reviews laboratory testing results and enters data into the Laboratory Information Management System (LIMS)
Performs environmental monitoring of controlled manufacturing environments
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
Identifies and solves problems while consulting and under the direction of management
Assists with laboratory equipment qualification and validation activities
Participates in project developments from concept through execution ensuring alignment with organizational goals. Performs other duties as assigned

Knowledge Skills or Abilities

Knowledge of aseptic techniques and behaviors
Effective communication both written and verbal
Technical writing and problem-solving skills
Ability to complete work both independently and under guidance from Supervision
Ability to systematically approach daily tasks
Ability to effectively collaborate with coworkers and internal clients
Knowledge of United States Pharmacopeia and European Pharmacopeia
Ability to support audit readiness for the laboratory
Willingness to incorporate lean lab and six sigma principles into the work environment
Ability to manage and complete tasks according to a structured plan
Knowledge and familiarity with data management systems (e.g. TrackWise LIMS) and capability to learn basic use and navigation within the systems
Must be flexible to support 24/7 manufacturing facility

Minimum Education and Experience Requirements

High School Diploma/GED with 6 years of Microbiology experience; or
Associates degree in Life Science Pharmaceutical or related field with 2-4 years of Microbiology experience; or
Bachelors degree in Life Science or Biology with 1-2 years of Microbiology experience

Experience with data management systems (e.g. LIMS TrackWise)

Preferred Education and Experience Requirements

2 years of CGMP laboratory experience

PHYSICAL REQUIREMENTS

PHYSICAL DEMANDS
Will work in environment which may necessitate respiratory protection. X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. X No Yes
Ability to inspect or perform a task with 20/20 corrected vision visual acuity including distinguishing color. X No Yes

WORKING ENVIRONMENT

PHYSICAL DEMANDS
Ability to ascend or descend ladders scaffolding ramps etc. X No Yes
Ability to stand for prolonged periods of time. No X Yes 60-120 minutes (If yes may specify frequency/duration: up tominutes)
Ability to sit for prolonged periods of time. No X Yes 60-120 minutes (If yes may specify frequency/duration: up tominutes)
Ability to conduct activities using repetitive motions that include wrists hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. No X Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes 10 lbs. 33 lbs.
Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions. No X Yes

ENVIRONMENTAL CONDITIONS
Will work in warm/cold environments. No X Yes 2-8 C Range (If yes specify approximate temperature ranges.)
Will work in outdoor elements such as precipitation and wind. X No Yes
Will work in small and/or enclosed spaces. X No Yes
Will work in heights greater than 4 feet. X No Yes

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 Associate 2 Quality Control (QC) Microbiology is responsible for performing routine microbiological testing of clean utility environmental monitoring and manufacturing batch samples. This role performs routine laboratory testing and support activities and actively participates i...