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QA Specialist - Level 2 US_AGS

Lancesoft

  • King of Prussia, PA
  • 30+ days ago
  • $1

Highlights

There is a high volume of data that requires a thorough review using ALCOA principles, attention to detail, meeting turn around times for batch release, adhering to procedures, training others and work with minimal supervision. G Separations- such as CGE/Client-SDS/HPLC/cIEF, Immunoassay- ELISA/qPCR/SPR/Bioassay, Compendia and/or Microbiology-Bioburden/Endotoxin).

Numbers & Facts

LocationKing of Prussia, PA
IndustryStaffing/Employment Agencies
Salary$1
Company Size2,000 to 2,499 employees
Year Founded2000
Websitehttp://www.lancesoft.com/

Description

Job Title: Quality Data Reviewer
Location: 709 Swedeland Road, King of Prussia, PA 19406
Duration: 9-month contract

Quality Data Reviewer will:
  • Ensure all data reviewed is accurate, complete, and compliant with internal procedures and regulatory requirements.
  • Participate in audits and inspections as needed, providing accurate and thorough documentation to support compliance efforts.
  • Identify opportunities to improve the efficiency and accuracy of the data review process.
  • Manage the process of data lifecycle activities, including review, approval, and archiving of laboratory records.
  • Communicate effectively with stakeholders to ensure alignment on priorities and timelines.
  • Continuously expand knowledge of quality systems, data review tools, and product-specific requirements.
  • Regularly update tracking tools or systems to provide visibility into review progress and outstanding items.
  • Actively participate in team meetings, providing updates on progress and sharing insights to improve overall performance.
  • Ensure all documentation reviewed meets internal and external standards for accuracy, completeness, and clarity.

Requirements:
  • Bachelors Degree or 2 years of industry experience Area of specialization in Biology, Biochemistry, Microbiology or equivalent technical discipline.
  • There is a high volume of data that requires a thorough review using ALCOA principles, attention to detail, meeting turn around times for batch release, adhering to procedures, training others and work with minimal supervision.
  • Experience with laboratory functionality and technical understanding of analytical assays is necessary to execute job functions
  • Attention to detail
  • Working knowledge of cGXP, Data integrity, ALCOA principles
  • System experience preferred- SAP/ERP, LES, Webstatistica, Empower, Hamilton
  • Analytical experience preferred (e.G Separations- such as CGE/Client-SDS/HPLC/cIEF, Immunoassay- ELISA/qPCR/SPR/Bioassay, Compendia and/or Microbiology-Bioburden/Endotoxin)
  • Experience using Excel, Word and Powerpoint
  • Strong organizational and task management skills
  • Strong leadership skills
  • Strong data analysis, data trending and communication skills
  • Ability to work independently or as part of a team with minimal supervision

About Company

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

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