QA Data Reviewer

Johnson Service Group (JSG) is currently looking for a QA Data Reviewer to complete data reviews for stability testing to meet filing timelines for our R&D partners.

This is a contract opportunity with a multinational pharmaceutical and biotechnology company located in Upper Merion PA.

The role has a chance of converting to direct hire.

Pay $39/hour Description 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.

Role is in a fast-paced environment within a team that supports all QC testing (Raw Materials, Biochemistry and Microbiology). The team offers a unique opportunity to work with different departments within QC as well as Quality Assurance and R&D partners.

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.

Johnson Service Group (JSG) is an Equal Opportunity Employer.

JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.

Allen Mudalel 515 Grove St.

Suite 3G • Haddon Heights, NJ 08035 • jsginc.com

Full Time