Data Reviewer-Senior Scientist, Quality Control
Amneal Pharmaceuticals
4 hours ago
On-site
Piscataway, NJ
Operations
The Scientist 3 - QC is responsible for testing raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples, calculating and reporting results on applicable specification documents, and participating in method transfer activities. Provides feedback on systems and analytical procedures to support continuous improvement and compliance enhancement.
Responsibilities:
- Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products (including stability) per written methods, material specifications, and SOPs; comply with cGMP, SOPs, and STPs and applicable state/federal regulations.
- Participate in project work; perform process validation and cleaning validation/verification testing; assist with analytical, instrument, and software problems.
- Use analytical/testing equipment (sonic sifter, laser diffraction, Karl Fischer, UV-Vis/IR spectrophotometers, HPLC, TLC, pH meter, dissolution); calibrate HPLC, dissolution apparatus (auto-sampler/in-line UV), pH meters, analytical balances, and Karl-Fischer titrator.
- Document analysis steps; calculate and report results; participate in laboratory result investigations; review data for completeness and specification compliance.
- Report abnormal findings to Supervisor; perform in-depth review of analytical records/reports to ensure technical correctness and specification compliance.
Additional Responsibilities:
- Assist with non-routine special projects (e.g., OOS and out-of-alert limit investigations).
- Remove expired chemicals and reference standards from lab area.
- Calibrate HPLC, GC, and other equipment as assigned.
- Assist with hands-on training of newly hired Technicians or Scientists 1 and 2.
Qualifications:
Education:
- BA/BS in Chemistry or related science discipline (Required)
- MS/MA in Chemistry or related science discipline (Preferred)
Experience:
- 5+ years testing chemicals/pharmaceutical products (with BA/BS)
- 3+ years testing chemicals/pharmaceutical products (with MS/MA)
Specialized Knowledge / Skills:
- In-depth analytical chemistry knowledge (spectrophotometric, dissolution/drug release, chromatographic; physical parameter measurements such as viscosity, particle size/droplet size by laser diffraction, melting point by DSC, water content by TGA, XRPD identification, etc.).
- Ability to follow compendial procedures (USP/EP/BP/JP).
- Apply cGMP requirements for a quality control laboratory.
- Advanced technical skills to troubleshoot complex analytical/instrument issues and report actions to management.
- Ability to identify trends in analytical data.
Benefits/Compensation:
- Base salary range: $85,000–$105,000 per year.
- Short-term incentive opportunity (bonus/performance-based award) within first 12 months.
Responsibilities:
- Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products (including stability) per written methods, material specifications, and SOPs; comply with cGMP, SOPs, and STPs and applicable state/federal regulations.
- Participate in project work; perform process validation and cleaning validation/verification testing; assist with analytical, instrument, and software problems.
- Use analytical/testing equipment (sonic sifter, laser diffraction, Karl Fischer, UV-Vis/IR spectrophotometers, HPLC, TLC, pH meter, dissolution); calibrate HPLC, dissolution apparatus (auto-sampler/in-line UV), pH meters, analytical balances, and Karl-Fischer titrator.
- Document analysis steps; calculate and report results; participate in laboratory result investigations; review data for completeness and specification compliance.
- Report abnormal findings to Supervisor; perform in-depth review of analytical records/reports to ensure technical correctness and specification compliance.
Additional Responsibilities:
- Assist with non-routine special projects (e.g., OOS and out-of-alert limit investigations).
- Remove expired chemicals and reference standards from lab area.
- Calibrate HPLC, GC, and other equipment as assigned.
- Assist with hands-on training of newly hired Technicians or Scientists 1 and 2.
Qualifications:
Education:
- BA/BS in Chemistry or related science discipline (Required)
- MS/MA in Chemistry or related science discipline (Preferred)
Experience:
- 5+ years testing chemicals/pharmaceutical products (with BA/BS)
- 3+ years testing chemicals/pharmaceutical products (with MS/MA)
Specialized Knowledge / Skills:
- In-depth analytical chemistry knowledge (spectrophotometric, dissolution/drug release, chromatographic; physical parameter measurements such as viscosity, particle size/droplet size by laser diffraction, melting point by DSC, water content by TGA, XRPD identification, etc.).
- Ability to follow compendial procedures (USP/EP/BP/JP).
- Apply cGMP requirements for a quality control laboratory.
- Advanced technical skills to troubleshoot complex analytical/instrument issues and report actions to management.
- Ability to identify trends in analytical data.
Benefits/Compensation:
- Base salary range: $85,000–$105,000 per year.
- Short-term incentive opportunity (bonus/performance-based award) within first 12 months.