QA Specialist - Level 2 US_AGS

Lancesoft

King of Prussia, PA

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JOB DETAILS

SALARY

SKILLS

Analysis Skills, Assays, Biochemistry, Biological Assay, Biology, Communication Skills, Data Analysis, Data Management, Data Processing, Data Quality, Detail Oriented, Documentation Review, GCP (Good Clinical Practices), GxP, High Performance Liquid Chromatography (HPLC), Immunoassays, Laboratory, Leadership, Microbiology, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Organizational Skills, Performance Management, Process Management, Product Reviews, Quality Assurance, Real-time PCR (qPCR), Regulatory Requirements, SAP ECC (fka SAP R/3 and SAP ERP), Software Administration, Support Documentation, Team Player, Trend Analysis

LOCATION

King of Prussia, PA

POSTED

5 days ago

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 the Company

Lancesoft

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.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/