Laboratory Quality Analyst

Eurofins - King of Prussia, PA

Full-time - Entry Level

King of Prussia, PA

Professional, Scientific, and Technical Services

About the position

The Laboratory Quality Analyst is responsible for ensuring the quality and compliance of laboratory and facility water systems through rigorous testing and GMP reviews. This role involves conducting microbiological and analytical testing, managing sample receipt and distribution, and maintaining laboratory equipment. The analyst will also participate in investigations and prepare reports to support quality assurance processes.

Responsibilities

• Conduct GMP review of microbiological testing of facility and laboratory water purification system samples, including LAL and Bioburden tests.
• Perform GMP review of analytical testing for water purification system samples, including TOC, Conductivity, and EU WFI Chemical Testing.
• Review Qualification and Media Release testing under GMP standards.
• Evaluate facility cleaning data and in-processing testing, including endotoxin, bioburden, BI, HPLC, Protein Concentration, pH, and Osmolality.
• Initiate and follow up on exceeded alert and action limits as per procedures.
• Assist in the preparation of quarterly trending reports.
• Conduct GMP review of raw materials for general appearance/identifications and FTIR.
• Review house gas/air sampling and testing under GMP.
• Initiate and follow up on OOS and action limits per procedure.
• Manage electronic and physical receipt, log-in, and distribution of samples and testing materials.
• Ensure proper sample custody chain by discarding/completing samples as necessary.
• Prepare and ship samples/materials, including aliquoting bulk samples, assay standards, assay controls, and custom assay reagents.
• Assist in updating and writing SOPs for laboratory processes.
• Perform routine calibration and maintenance of laboratory equipment, including pipettes, balances, plate readers, and pH meters.
• Clean incubators, laminar flow hoods, biosafety cabinets, refrigerators, and cold rooms; defrost freezers and prepare disinfectants.
• Maintain solvent wash bottles and clean water baths; conduct GMP lab sweeps.
• Investigate equipment out-of-tolerance (OOT) issues and maintain documentation for refrigerators, freezers, incubators, and pipettes.
• Participate in investigations associated with deliverables supporting the task order.

Requirements

• B.S. degree with 1 year of Quality Control experience in the Pharmaceutical industry.
• Experience in a Quality Control Lab is preferred.
• Work experience in a cGMP environment is required.
• Proficiency in Microsoft Word and Excel is required.
• Authorization to work in the United States indefinitely without restriction or sponsorship.

Nice-to-haves

• Strong computer, scientific, and organizational skills.
• Excellent communication (oral and written) and attention to detail.
• Ability to work independently and as part of a team, self-motivated, adaptable, and positive attitude.
• Ability to learn new techniques and perform multiple tasks simultaneously.

Benefits

• Comprehensive medical coverage, dental, and vision options.
• Life and disability insurance.
• 401(k) with company match.
• Paid vacation and holidays.