GMP Data Reviewer

• Water Systems
  • GMP review of microbiological testing of the facility and/or laboratory water purification system samples. Tests included are LAL and Bioburden.
  • GMP review of analytical testing of the facility and/or laboratory water purification system samples. Tests included are TOC Conductivity EU WFI Chemical Testing.
  • GMP review of Qualification and Media Release testing.
  • GMP review of facility cleaning data and in-processing testing including but not limited to endotoxin bioburden BI HPLC Protien Concentration pH and Osmolality.
  • Initiation and follow-up of exceeded alert and action limits per procedures.
  • Participate in preparation of quarterly trending reports
• Raw Materials
  • GMP review of general appearance/identifications and FTIR
  • GMP review of house gas/air sampling and testing
  • Initiation and follow-up of OOS and action limits per procedure
  • Electronic and physical receipt log-in and distribution of samples and testings materials coming into QC.
  • Discarding / completing sample custody chain
  • Preparation and shipping of sample/materials
  • Aliquoting of bulk samples assay standards assay controls and custom assay reagents
• Laboratory Support
  • Assist in updating and writing SOPs
  • Routine calibration and maintenance of laboratory equipment which includes pipettes balances plate readers and pH meters
  • Cleaning of incubators laminar flow hoods and biosafety cabinets
  • Cleaning of refrigerators and cold rooms
  • Defrosting of freezers
  • Disinfectant preparation
  • Maintenance of solvent wash bottles
  • Cleaning of water baths
  • GMP lab sweeps
  • Equipment out-of-tolerance (OOT) and refrigerator freezer incubator and pipette investigations
  • Weekly distributed control system (DCS) documentation review and maintenance
  • Participate as required in any investigations associated with their deliverables supporting this task order

Qualifications :

• 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
• Experience with Microsoft Word and Excel is required
• 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 adaptability and a positive attitude
• Ability to learn new techniques perform multiple tasks simultaneously keep accurate records follow instructions and comply with company policies
• Authorization to work in the United States indefinitely without restriction 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