Overview
QC Senior Specialist – Analytical Science Jobs in Boston, Massachusetts, USA at BioPharma Consulting JAD Group
QC Senior Specialist – Analytical Science (Contract)
The QC Senior Specialist – Analytical Science has experience executing and/or reviewing quality control analysis in a GMP laboratory. This role is responsible for reviewing of small molecule analytical data, reports, methods, method validations/transfers, regulatory filings, and other documentation to support outsourced quality control testing. The Sr. Specialist may also manage trending of analytical data for continued process verification (CPV), investigations, change controls and may have potential vendor interaction.
This is a temporary position and is designated as hybrid (on-site at least three days a week).
Key Duties and Responsibilities:
Review raw data from routine QC analysis including HPLC, dissolution, KF, GC, bulk density, PSD, physical form (XRD), appearance, and identification
QC check data in reports, regulatory filings, and other documentation
Manage workflows and approval in Veeva document management system
Distribute documents internally and externally as needed
Perform analytical data trending to support continued process verification
Document external analytical investigations (e.g. OOS, OOT & OOE)
With supervision, interact with external laboratories to manage analytical documentation
Other duties as assigned
Knowledge and Skills:
Experience performing analytical tests or reviewing analytical lab data for small molecule drug substance, drug product intermediate, or drug product
Prior experience working in a controlled environment (GMP or similar)
Prior experience with Microsoft Office, Veeva, JMP, Airtable, Smartsheet and Docu Sign is advantageous
Requirements:
Bachelor’s in Chemistry, Chemical Engineering, Pharmaceutical Chemistry, or other natural science with 5+ years of experience OR
Master’s in Chemistry, Chemical Engineering, Pharmaceutical Chemistry, or other natural science with 2+ years of experience
Seniority level:
Mid-Senior level
Employment type:
Contract
Job function:
Science
Industries:
IT Services and IT Consulting
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Title: QC Senior Specialist – Analytical Science
Company: BioPharma Consulting JAD Group
Location: Boston, Massachusetts, USA
Category: Quality Assurance – QA/QC (Data Analyst), Healthcare (Data Scientist)
