QC Associate 1, Environmental Monitoring (Sunday – Wednesday 10am – 8pm) Position Available In Durham, North Carolina

QC Associate 1, Environmental Monitoring (Sunday – Wednesday 10am – 8pm)
Job Locations
US-NC-Research Triangle Park
Posted Date
1 week ago
(4/23/2025 5:47 PM)
Requisition

ID 2025-34250

Category Quality Assurance Company (Portal Searching) Diosynth Biotechnologies
Position 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 We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Diosynth Biotechnologies, we partner with our clients to deliver rbinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is tobine 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, andpressed 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)pliance
• 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 withanizational 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
• Effectivemunication, both written and verbal
• Basic technical writing and problem-solving skills
• Ability toplete 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 andplete 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 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 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 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 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 ismitted to providing equal opportunities in hiring, promotion and advancement,pensation, 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 amodation inpleting this application, interviewing,pleting any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (HR_FDBUfujifilm). Options