Job Description

Water Systems

• Perform GMP reviews of microbiological testing data for facility and laboratory water purification systems, including LAL and bioburden results.
• Review analytical testing data for water systems, including TOC, conductivity, and EU WFI chemical testing.
• Review qualification and media release testing documentation.
• Review facility cleaning and in-process testing data such as endotoxin, bioburden, biological indicators (BI), HPLC, protein concentration, pH, and osmolality.
• Initiate and follow up on deviations when alert or action limits are exceeded, by established procedures.
• Support the preparation and completion of quarterly trend reports.

Raw Materials

• Conduct GMP reviews of raw material test data, including general appearance, identification, and FTIR results.
• Review testing data for house gas and air sampling.
• Initiate and follow up on out-of-specification (OOS) results and excursions beyond action limits per procedural requirements.
• Manage the electronic and physical receipt, log-in, and distribution of incoming QC samples and testing materials.
• Complete sample custody chains and ensure proper sample disposal.
• Prepare and ship samples or materials to internal and external labs.
• Perform aliquoting of bulk samples, assay standards, controls, and custom reagents.

Laboratory Support

• Assist in drafting, revising, and maintaining standard operating procedures (SOPs).
• Perform routine calibration and maintenance of laboratory equipment including pipettes, balances, plate readers, and pH meters.
• Clean incubators, biosafety cabinets, laminar flow hoods, refrigerators, and cold rooms; defrost freezers as needed.
• Prepare disinfectant solutions and maintain solvent wash bottles and water baths.
• Conduct regular GMP lab sweeps to maintain a compliant and orderly environment.
• Support investigations related to equipment out-of-tolerance (OOT) events and temperature excursions involving refrigerators, freezers, incubators, and pipettes.
• Review and maintain weekly Distributed Control System (DCS) documentation.
• Participate in investigations and tasks relevant to assigned responsibilities under the task order.

Qualifications

• Bachelor’s degree in a scientific discipline, with at least 1 year of experience in Quality Control within the pharmaceutical industry
• Prior experience in a Quality Control laboratory environment is preferred
• Hands-on experience working in a cGMP-regulated setting is required
• Proficiency with Microsoft Word and Excel
• Strong scientific, computer, and organizational skills
• Excellent written and verbal communication, with high attention to detail
• Demonstrated ability to work both independently and collaboratively in a team environment
• Self-motivated, adaptable, and maintains a positive, solution-focused attitude
• Capable of learning new techniques quickly, managing multiple tasks, maintaining accurate records, and adhering to SOPs and company policies
• Must be authorized to work in the United States without restrictions or sponsorship

Additional Information

What to Expect in the Hiring Process:

• 10-15 Minute Phone Interview with Region Recruiter
• 45-60 Minute Virtual Interview with Manager and/or Group Leader

Additional Details:

The position is permanent, on-site and full-time, Monday-Friday from 7 am-3 p m. Candidates living within a commutable distance of King of Prussia, PA, and the surrounding areas are encouraged to apply.

Excellent full-time benefits include:

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

Eurofins Lancaster Laboratories Professional Scientific Services® (PSS) is a global, award-winning insourcing solution that places our people at our clients’ sites, dedicated to running and managing laboratory services while eliminating headcount, co-employment, and project-management worries.

We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR, and a great place to work best practices, to recruit, hire, train, and manage highly qualified scientists to perform laboratory services using our clients’ quality systems and equipment.

To learn more about Eurofins Lancaster Laboratories, please explore our website www.eurofinsus.com.

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.