GMP Compliance Technician

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 :

• Bachelors 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 pm. 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 .

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

Remote Work :

No

Employment Type :

Full-time