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

Position Overview

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.

Company Overview

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

Job Description

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 non-conformances) within quality systems• Identifies and solves problems while consulting and under the direction of management• Participates in project developments from concept through execution, 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 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• 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• Associate’s degree in Life Science, Pharmaceutical, or related field with 2 years of Microbiology experience; or• Bachelor’s degree in Life Science or Biology with no previous experience• Experience with data management systems (e.g., LIMS, TrackWise)

 

Experience Requirements 

 

• 1-2 years of CGMP laboratory experience

 

PHYSICAL DEMANDS

 

Will work in environment which may necessitate respiratory protection. No X YesMay work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No YesWill work in environment operating a motor vehicle or Powered Industrial Truck. X No YesAbility to discern audible cues. X No YesAbility 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 YesAbility to stand for prolonged periods of time. No X Yes 60-120 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)Ability to sit for prolonged periods of time. No X Yes 60-120 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. No X YesAbility to operate machinery and/or power tools. No X YesAbility 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