Quality Lab Associate I

Job Description

Job Summary:

• This section focuses on the main purpose of the job in one to four sentences.
• Primarily support QC Microbiology Laboratory operations.
• 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.

Duties & Responsibilities:

• 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 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 client 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.

Required Qualifications:

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

knowledge, skills, abilities:

• 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.

Education & Experience:

• Include the education and experience that is necessary to perform the job satisfactorily.
• Bachelor’s degree in microbiology or biological science with minimum of 2 years experience in a laboratory setting.