Senior Scientist, Quality Control
Amneal Pharmaceuticals
9 days ago
On-site
Brookhaven, NY
Operations
The Scientist 3 - QC is responsible for testing raw materials, in-process and finished pharmaceutical dosage forms, products on stability, and cleaning verification samples following written procedures and applicable SOPs; calculate and report results on applicable specification documents; and participate in method transfer activities within departments or between facilities/organizations. Provides feedback on systems and analytical procedures to support continuous improvement and compliance.
Essential Functions:
- Perform physical/chemical analysis of raw materials, in-process, finished products, and stability samples per written methods, specifications, and SOPs; comply with cGMP and state/federal regulations.
- Participate in project work; perform process validation and cleaning validation/verification testing; assist with analytical, instrument, and software issues.
- Use lab instruments (e.g., sonic sifter, laser diffraction, Karl Fischer, UV-Vis/IR spectrophotometers, HPLC/UV & conductivity, TLC, pH meter, dissolution) and calibrate HPLC, dissolution apparatus (auto-sampler/inline UV), pH meters, analytical balances, and Karl-Fischer titrator.
- Document analysis steps, calculate/report results, and participate in laboratory result investigations.
- Review data for completeness and specification compliance; report abnormalities to the Supervisor and perform in-depth analytical record reviews as assigned.
Additional Responsibilities:
- Assist with non-routine special projects (e.g., OOS/OAL investigations).
- Remove expired chemicals/reference standards from the lab area.
- Perform calibration of HPLC, GC, and other equipment as assigned.
- Assist with hands-on training of Technicians and Scientists 1–2.
Qualifications:
- Required: BS/BA in Chemistry or related science; 5+ years testing chemicals/pharmaceutical products.
- Preferred: MS/MA in Chemistry or related science; 3+ years testing with a Master’s.
- Specialized knowledge: in-depth analytical chemistry techniques; ability to follow compendial procedures (USP/EP/BP/JP); apply cGMP in a QC lab; troubleshoot complex analytical/instrument problems; identify trends in analytical data.
- Additional requirement: successful completion of an OSHA-compliant Respirator Fit Test.
Essential Functions:
- Perform physical/chemical analysis of raw materials, in-process, finished products, and stability samples per written methods, specifications, and SOPs; comply with cGMP and state/federal regulations.
- Participate in project work; perform process validation and cleaning validation/verification testing; assist with analytical, instrument, and software issues.
- Use lab instruments (e.g., sonic sifter, laser diffraction, Karl Fischer, UV-Vis/IR spectrophotometers, HPLC/UV & conductivity, TLC, pH meter, dissolution) and calibrate HPLC, dissolution apparatus (auto-sampler/inline UV), pH meters, analytical balances, and Karl-Fischer titrator.
- Document analysis steps, calculate/report results, and participate in laboratory result investigations.
- Review data for completeness and specification compliance; report abnormalities to the Supervisor and perform in-depth analytical record reviews as assigned.
Additional Responsibilities:
- Assist with non-routine special projects (e.g., OOS/OAL investigations).
- Remove expired chemicals/reference standards from the lab area.
- Perform calibration of HPLC, GC, and other equipment as assigned.
- Assist with hands-on training of Technicians and Scientists 1–2.
Qualifications:
- Required: BS/BA in Chemistry or related science; 5+ years testing chemicals/pharmaceutical products.
- Preferred: MS/MA in Chemistry or related science; 3+ years testing with a Master’s.
- Specialized knowledge: in-depth analytical chemistry techniques; ability to follow compendial procedures (USP/EP/BP/JP); apply cGMP in a QC lab; troubleshoot complex analytical/instrument problems; identify trends in analytical data.
- Additional requirement: successful completion of an OSHA-compliant Respirator Fit Test.