Senior GMP Data Review Specialist
Eurofins Lancaster Laboratories Professional Scientific Services, LLC

Job Info

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Senior GMP Data Review Specialist

Employee Responsibilities:

• 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 SOP's
  • 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
    

The Ideal Candidate would possess:

• 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

Minimum 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
• Authorization to work in the United States indefinitely without restriction or sponsorship

What we offer:

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Position is full-time, Monday-Friday, 7 a.m.- 3 p.m., with overtime as needed. Candidates currently living within a commutable distance of King Of Prussia, Pennsylvania are encouraged to apply.

Eurofins Lancaster Laboratories Professional Scientific Services ® (PSS) is a global, award-winning insourcing solution that places our people at our clients' site 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 great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client's quality systems and equipment.

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

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

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