Quality Laboratory Associate I

United Pharma; Illinois; On-site; USD 52,000 - 78,000; Full time

Job summary

United Pharma seeks a laboratory technician to support biological testing for biologics and drugs across all manufacturing stages, including raw materials, in-process samples, and finished products, and to monitor environmental and critical systems microbiology.

You will perform routine analyses, prepare media, use LIMS and instrumentation, maintain data integrity, assist investigations, and ensure compliance with FDA, QSR, and cGMP, working in Drug Delivery and Penicillin facilities as required.

Qualifications

• Background in Biology and Microbiology principles including aseptic technique.
• Proficient in LIMS and laboratory instrumentation.
• Ability to multitask, be detail oriented, and have good reading comprehension.
• GLP and pharmaceutical aseptic processing cGMP knowledge is preferred but not required.
• Strong technical writing and knowledge of structured root cause investigations (DMAIC).
• Ability to work independently and as part of a team.
• Self-motivation and adaptability in a dynamic environment.
• Ability to lift up to 50 pounds when required.

Responsibilities

• Conduct microbial analyses on raw materials, in-process samples, finished products and environmental samples.
• Perform routine facility environmental monitoring and critical systems monitoring.
• Prepare media and reagents used in the laboratory.
• Operate laboratory instrumentation and data systems (e.g., pH meters, SAS, Autoclave, LIMS).
• Monitor inventory and stock supplies; order and receive items as needed.
• Maintain a clean, safe laboratory area and perform housekeeping.
• Investigate nonconformances, review data, assess root causes, and document CAPAs.
• Maintain data integrity and compliance with SOPs, FDA, QSR and cGMP.
• Follow client procedures and policies on cGMPs and safety.
• Contribute to other laboratory tasks and projects as assigned.
• Work in both Drug Delivery and Penicillin facilities as needed.

Skills

Aseptic technique

Attention to detail

Reading comprehension

Independent work

Teamwork

Self-motivation

Education

BSc in Biology or Microbiology

Tools

LIMS

Job description

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.

Essential Duties and Responsibilities:

• 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.

Qualifications:

• 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.