QA Specialist

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.

Pay Range: $35 - $39.

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.

Education:

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.

Must be able to work W2.

About Alphanumeric Systems Inc.:

Alphanumeric is a dynamic company born of a diverse mindset and held to a distinctly high standard. You may know us as a tech and communications firm established in 1979, but we also lead life science and healthcare organizations toward a more efficient future across the globe, bringing patients and providers together to build personalized relationships that fit their needs.But at our core, we are a family with a shared and passionate dedication to our customers. We treat our candidates as amazing (because they are!)Apply today to join our family and Make Your Mark!

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