QC Data Reviewer

Cambridge, MA

Posted: 07/10/2019 Employment Type: Contract Industry: Life Sciences Job Number: 229864
Required Skills:

2+ years of experience in a QC Lab environment
Experience in reviewing HPLC based analytical methods
Participate in CAPS & Change Controls

Desired Skill:

Knowledgeable in most or all the following: Particle Size, Reverse Phase HPLC, pH, Osmolality, and standard wet chemistry techniques 


Job Description:

Responsibilities:

·        Perform data review of in-process, release and stability testing of raw materials, bulk drug product, and vialed drug product in a cGMP setting

·        Draft certificates of analysis for bulk drug product and vialed drug product

·        Review certificates of analysis for bulk drug product and vialed drug product

·        Participate in investigations for OOS/OOT results and Unplanned Events (deviations)

·        Participate in CAPAs, and Change Controls

·        Work cross-functionally with quality assurance, process development, manufacturing, and analytical development to drive closure of quality systems items (OOS/OOT investigations, Unplanned Events, CAPAs, Change Controls)

 

  Qualifications:

Education:

·        BA/BS degree in Biochemistry (or a related field) or related experience

 

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