QC Senior Specialist - Analytical Science (Contract) 11111 - Boston
Job Description:
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.
Note: There will be no physical lab work required - but past lab experience preferred.
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) Education and Experience:
- Prior experience with Microsoft Office, Veeva, JMP, Airtable, Smartsheet and DocuSign is advantageous.
Education and Experience:
- Bachelor's or Master's in Chemistry, Chemical Engineering, Pharmaceutical Chemistry, or other natural science
- Typically requires the following, or the equivalent combination of education and experience: Master's and 2+ years, or Bachelor's and 5+ years.
Pay Range:
$50-$60/hr
Requisition Disclaimer:
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law.
In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
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No C2C or Third-Party Vendors