QC Associate 1 Environmental Monitoring Wednesday - Saturday 10am - 8pm

The Associate 1 Quality Control (QC) Environmental Monitoring (EM) is an entry level position responsible for performing site environmental and clean utility monitoring within the manufacturing classified areas. This role performs routine laboratory testing and support activities in continuous improvement initiatives.

We are Advancing tomorrows 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 tomorrows medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies and programs with the ultimate goal of delivering products that transform the lives of patients.

Major Accountabilities

Supports manufacturing operations through routine EM of classified production areas
Provides facility support through the collection and testing of site clean utilities (e.g. water steam and compressed gases)
Performs basic microbiological testing per department standing operating procedures (SOPs) and test methods for samples associated with Environmental and Clean Utility Monitoring
Performs subculturing and Gram staining of recovered microbiological isolates
Reviews laboratory testing results and enters data into the Laboratory Information Management System (LIMS)
Ensures laboratory maintains inspection readiness data integrity and Current Good Manufacturing Practice (CGMP) compliance
Operates facility and laboratory autoclaves
Assists management with technical services such as initiating events (e.g. deviations and nonconformances) within quality systems
Identifies and solves problems while consulting and under the direction of management
Participates in project developments from concept through ensuring alignment with organizational goals.

Performs other duties as assigned.

Knowledge Skills or Abilities

Ability to aseptically gown into classified manufacturing spaces
Knowledge of aseptic techniques and behaviors and working within ISO 8 and ISO 7 environments
Effective communication both written and verbal
Basic technical writing and problemsolving 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
Familiarity with 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
Basic understanding and familiarity 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 and Experience Requirements

High School Diploma/GED with 4 years of Microbiology experience; or
Associates degree in Life Science Pharmaceutical or related field with 2 years of Microbiology experience; or
Bachelors degree in Life Science or Biology with no previous experience
Experience with data management systems (e.g. LIMS TrackWise)

Experience Requirements

12 years of CGMP laboratory experience

PHYSICAL DEMANDS

Will work in environment which may necessitate respiratory protection. No X 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

Ability to ascend or descend ladders scaffolding ramps etc. X No Yes
Ability to stand for prolonged periods of time. No X Yes 60120 minutes (If yes may specify frequency/duration: up tominutes)
Ability to sit for prolonged periods of time. No X Yes 60120 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 X 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 28 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

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.

If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department .