<h3>Job Description</h3>
About Us
We are a boutique biologics CDMO located in Newton MA . We are looking for self driven QC expert with technical expertise in biologics who will have&nbsp;end-to-end ownership of QC and EM investigations ensuring they are scientifically rigorous, risk-based, and inspection-ready
 
Key Responsibilities:&nbsp;
<ul>
<li>Own and close deviations, OOS/OOT, and EM investigations</li>
<li>Lead root cause analysis and determine appropriate CAPAs</li>
<li>Assess analytical, microbiological, and biological variability</li>
<li>Interface directly with QA and cross-functional stakeholders</li>
<li>Defend the investigation conclusion</li>
<li>Drive consistency and continuous improvement in investigation practices</li>
</ul>
&nbsp;
Qualifications:&nbsp;
<ul>
<li>BS in Chemistry, Biochemistry, or related field (MS preferred)</li>
<li>6–8 years GMP experience with&nbsp;≥3 years owning investigations</li>
<li>Strong background in biologics QC and microbiology/EM investigations</li>
<li>Direct experience in supporting inspections</li>
<li>Demonstrated ability to make independent, science-based decisions</li>
</ul>

Quality Control Sr. Scientist/Supervisor

Job Description