Quality Laboratory Associate

This section focuses on the main purpose of the job in one to four sentences. .

This position encompasses biological testing support for pharmaceutical products (biologics and drugs) through all stages of the manufacturing process including incoming raw materials, in-process samples, and finished products and includes facility environmental and critical systems microbiological monitoring.

This section contains a list of five to eight primary responsibilities of this role that account

for the majority of the work. The incumbent will perform other duties assigned.

• Conduct microbial analyses on raw materials, in-process, and finished products, and samples collected from the environmental monitoring programs and client’s manufacturing facility.
• Conduct routine facility environmental monitoring (i.e., surfaces, air, particulate and personnel monitoring) and critical systems monitoring (i.e., water, clean steam, process compressed air and nitrogen).
• Prepare media and reagents used within the laboratory.
• Use laboratory instrumentation (i.e., particle counters, pH meter, SAS, Autoclave) and computer systems (i.e., LIMS) to collect and record data.
• Monitor inventory of supplies, equipment, reagents and media. Order, receive and stock supplies as necessary.
• Maintain a clean, safe and organized laboratory area and perform regular laboratory housekeeping activities.
• Conduct and document laboratory and nonconformance investigations, including data review, root cause analysis, impact assessment, and development of appropriate corrective and preventive actions.
• Maintain data integrity and ensure compliance with company standard operating procedures, FDA, QSR and cGMP regulations.
• Follow, understand and comply with the client’s procedures and policies on cGMP’s and safety.
• Contribute to other laboratory tasks and projects as assigned.
• Will work in both Drug Delivery and Penicillin facilities as needed.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Must not be allergic to Penicillin and Cephalosporin or their related products and minerals.
• Background knowledge in basic Biology and Microbiology principles including aseptic technique is required.
• Proficient in LIMS (laboratory information management systems).
• Ability to handle multiple tasks concurrently, and in a timely fashion. Must be detail oriented, conscientious and have high reading comprehension skills.
• Knowledge of GLP and pharmaceutical aseptic processing cGMP requirements is preferred but not required.
• Demonstrated technical writing skills and knowledge of structured root cause investigation methodologies, including DMAIC (Define, Measure, Analyze, Improve, Control).
• Ability to work independently and as part of a team.
• Self-motivation, adaptability and a positive attitude in a highly dynamic environment.
• Ability to lift up to 50 pounds when required.