QC Associate II, Microbiology

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.

Responsibilities

- Perform routine, non-routine environmental monitoring (EM) of the GMP manufacturing facilities for total particulates, air viables, and surface viables.

- Initiate and participate in the investigations of EM excursions and assess any potential impact on product quality.

- Assist in trending EM data and generate quarterly reports and yearly reports.

- Perform routine monitoring of pharmaceutical water systems.

- Perform routine monitoring of pharmaceutical gas systems.

- Perform bioburden and endotoxin testing.

- Perform analysis and data analysis of in-process samples, APIs, and stability samples using existing methods.

- Support assay transfer, qualification and validation activities for client’s specific methods.

- Author and review Quality Control standard operating procedures (SOPs) and assay qualifications.

- Maintain QC lab equipment and provide assistance, as needed, during equipment and facility qualification activities.

- Interact closely with other departments to ensure efficient, compliant and timely execution of project activities.

- Provide assistance as needed to maintain functioning QC Laboratory, including material ordering, inventory control, general housekeeping and other duties.

- Assist in investigation and review of GMP quality events, including but not limited to deviations, out of specification reports, and audit findings.

- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results with a customer driven focus.

- Utilize laboratory equipment in accordance with established practices, including, but not limited to, particle counters, air samplers, microscopes, etc.

- Operate to the highest ethical and moral standards.

- Adhere to quality standards set by regulations and Abzena’s policies, procedures and mission.

- Communicate effectively with supervisors, colleagues and subordinates.

- Participate effectively as a team player in all aspects of Abzena business.

- Gown for and work in a cleanroom environment.

- Accurately and precisely document and record laboratory activities, results, and conclusions.

- Multi-task, organize and communicate with team.

Qualifications

- BS degree in a relevant discipline (e.g., microbiology, chemistry, biological sciences, bioengineering, etc.).

- 3-8 years of experience in environmental monitoring of GMP facilities.

- 3-8 years of experience working in a GMP microbiology lab.

- 3-8 years of experience with one or more of the methods such as: bioburden, endotoxin, total organic carbon, conductivity, or Gram staining.

- Knowledge of and experience in GMP, following standard test methods, or willingness to become GMP proficient.

Physical Requirements

- Environment: GMP-regulated Quality Control laboratory.

- Chemical Exposure: Frequent handling of organic solvents, acids, buffers, and standards (e.g., methanol, acetone, IPA, acetonitrile).

- 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).

- Safety Protocols: Strict adherence to the Chemical Hygiene Plan, SOPs, and Safety Data Sheet (SDS) instructions is required.

- PPE Requirements: Mandatory use of lab coats, nitrile gloves, and safety glasses. Tasks may require face shields, splash goggles, or respiratory protection.

- Daily Activities: Frequent pipetting, weighing, reagent preparation, and instrument operation. Handling of hazardous materials occurs inside laboratory hoods.

- Physical Effort: Regular sitting, standing, walking, bending, reaching, and repetitive hand movements.

- Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.

- Frequently lift and or move objects up to 30 pounds.

- Stand/walk during entire length of shift.

- Use arms, hands and fingers to handle, feel or reach.

- Ability to climb, balance, stoop, kneel, crouch, or crawl.

- Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.