Quality Lab Associate I

Planet Pharma; Round Lake (IL); Vor Ort; USD 26.000 - 40.000; Vollzeit

Zusammenfassung

Planet Pharma in Round Lake, IL, seeks a QC Microbiology Laboratory Associate to support microbial testing for raw materials, in-process samples, and finished products across both the Drug Delivery and Penicillin facilities. You will conduct environmental monitoring and ensure data integrity under cGMP and FDA guidelines.

Qualifications include a Bachelors in microbiology or biological science with 1–2 years in a lab, Penicillin allergy avoidance, and proficiency with LIMS and basic microbiology

Qualifikationen

• Must not be allergic to Penicillin or Cephalosporin or related products.
• Background knowledge in basic Biology and Microbiology principles including aseptic technique.
• Proficient in LIMS (laboratory information management systems).
• Ability to handle multiple tasks concurrently; must be detail oriented and have strong reading comprehension.
• Knowledge of GLP and pharmaceutical aseptic processing cGMP requirements is preferred.
• Experience with structured root cause investigation methodologies (DMAIC).
• Ability to work independently and as part of a team.

Aufgaben

• Conduct microbial analyses on raw materials, in-process, and finished products, and samples from environmental monitoring programs.
• Perform routine facility environmental monitoring (surfaces, air, particulates, personnel) and critical systems monitoring (water, clean steam, process gases).
• Prepare media and reagents for use in the laboratory.
• Operate laboratory instruments (e.g., particle counters, pH meter, SAS) and data systems (LIMS) to collect and document results.
• Monitor inventory and stock supplies; order and receive items as needed.
• Maintain a clean, safe, organized lab and perform housekeeping duties.
• Investigate laboratory nonconformances; document root cause analysis and corrective actions.
• Maintain data integrity and comply with SOPs, FDA, QSR and cGMP requirements.
• Follow cGMP and safety procedures and assist with other lab tasks and projects.

Kenntnisse

LIMS proficiency

Biology basics

Microbiology principles

Aseptic technique

Attention to detail

Reading comprehension

multitask

Teamwork

Ausbildung

Bachelor's degree in microbiology or biological science

Tools

LIMS

SAS

Autoclave

pH meter

Jobbeschreibung

Summary:

This section focuses on the main purpose of the job in one to four sentences. Primarily support QC Microbiology Laboratory operations at the facility in Round Lake, IL. 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.

Essential Duties and Responsibilities:

• Conduct microbial analyses on raw materials, in-process, and finished products, and samples collected from the environmental monitoring programs and 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 procedures and policies on cGMPs and safety.
• Contribute to other laboratory tasks and projects as assigned.
• Will work in both Drug Delivery and Penicillin facilities as needed.

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.

Education and/or Experience:

Bachelors degree in microbiology or biological science with minimum of 1-2 years experience in a laboratory setting.

This is a first-shift Thursday-Monday or Wednesday-Sunday position. Occasional off-shift and holiday work required. flexible days but Saturdays and Sundays are mandatory.

Pay range: 19-29/hr DOE