With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
The Quality Control Associate II is responsible for the routine, and non-routine Environmental Monitoring (EM) of manufacturing clean rooms, compressed gas system, and WFI systems. The QC Associate II will also focus on microbial testing and completion of in-process and release testing. Serves on team projects in the role of testing and investigations support. The QC Associate II is responsible for equipment setup, documentation, method transfer/qualification, training, and keeping up cGMP compliance and supports site initiatives and departmental goals.
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Responsibilities
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Perform routine, non-routine environmental monitoring (EM) of the GMP manufacturing facilities for total particulates, air viables, and surface viables.
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Provide assistance as needed to maintain functioning QC Laboratory, including material ordering, inventory control, general housekeeping and other duties.
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Assist in investigation and review of GMP quality events, including but not limited to deviations, out of specification reports, and audit findings.
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Utilize laboratory equipment in accordance with established practices, including, but not limited to, particle counters, air samplers, microscopes, etc.
Qualifications
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BS degree in a relevant discipline (e.g., microbiology, chemistry, biological sciences, bioengineering, etc.).
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3-8 years of experience with one or more of the methods such as: bioburden, endotoxin, total organic carbon, conductivity, or Gram staining.
Physical Requirements
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Chemical Exposure: Frequent handling of organic solvents, acids, buffers, and standards (e.g., methanol, acetone, IPA, acetonitrile).
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Hazard Exposure: Potential contact with materials classified as corrosive, flammable, toxic, carcinogenic, or reproductive hazards (e.g., boric acid, β-mercaptoethanol, sulfuric acid, silver nitrate).
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PPE Requirements: Mandatory use of lab coats, nitrile gloves, and safety glasses. Tasks may require face shields, splash goggles, or respiratory protection.
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Daily Activities: Frequent pipetting, weighing, reagent preparation, and instrument operation. Handling of hazardous materials occurs inside laboratory hoods.
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Physical Effort: Regular sitting, standing, walking, bending, reaching, and repetitive hand movements.
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Ability to climb, balance, stoop, kneel, crouch, or crawl.
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Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.
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$70,000 - $85,000 a year
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FLSA:Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
We are committed to providing an inclusive and accessible workplace. The essential functions of this role can be performed with or without reasonable accommodation. If you require an accommodation during the application process or to perform the job, please contact Human Resources.