Alphanumeric is hiring a QA Specialist - Level 1 to work in King of Prussia, PA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements.

This position performs a technical review of analytical data for Biochemistry and Compendial testing to support release, stability and tech transfer testing.

Techniques include but not limited to Separation and Immunoassay testing CGE, CE-SDS, HPLC, cIEF, ELISA, qPCR, SPR, and Bioassay.

This role is onsite in King of Prussia, PA.

Must be able to work through a W2 contract.

Must be legally allowed to work within the USA.

12 month duration contract.

Key Responsibilities:

• Review and approve laboratory data using the ALCOA principles.
• Ensure release and stability data is performed on schedule to support batch release.
• Assist with sample management upon completion of data approval.
• Support or Lead Level 1 Audits and Deviation Investigations.
• Archive Data per local procedures.
• Participate in regulatory audits as an SME in the data review process.
• Identify and lead continuous improvements around the data flow process.
• Review and/or transcribe stability and external party data.
• Author or revise documents for compliance, accuracy and clarity.
• 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/CE-SDS/HPLC/cIEF, Immunoassay- ELISA/qPCR/SPR/Bioassay) and/or Compendia
• 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

Job Requirements

• Bachelor's Degree. Biology, Microbiology.
• 5 years Industry Experience.
• Biology, Biochemistry, Microbiology or equivalent technical discipline.
• Scientific and technical understanding of the job duties and ability to follow procedures related to the responsibilities is needed to review analytical data to ensure results are adequate.
• Demonstrate the ability to interpret analytical data for accuracy, compliance and identify atypical results
• Experience working with Empower.