Lead Scientist- QC, Pharmaceutical

About the role:
This role is responsible for performing quality control laboratory testing (60%) and document review, investigations, and CAPA management (40%) within a pharmaceutical manufacturing environment. The position involves routine testing and analysis of finished products (tablets, capsules, soft gels) and raw materials, using a variety of analytical techniques and instrumentation.
A key component of this role is leading laboratory investigations, including deviations and out-of-specification (OOS) results, as well as authoring detailed investigation reports and supporting CAPA closure activities. The ideal candidate will have strong experience in technical writing, data review, and quality systems such as TrackWise and MasterControl, along with a solid background in oral solid dosage forms and GMP compliance.

Key Responsibilities
QC Laboratory Testing (60%)

• Perform routine testing and analysis of raw materials, in-process samples, and finished products.
  

• Conduct assays and analytical tests including identity (ID), content uniformity, blending uniformity, impurity testing, water content (Karl Fischer), disintegration, and hardness.
  

• Execute stability testing under ICH conditions and evaluate product performance over time.
  

• Operate, maintain, and troubleshoot analytical instruments including HPLC, UPLC, GC, FTIR, Karl Fischer, pH meters, and dissolution/visualization testers.
  

• Utilize Empower 3 or similar chromatography software for data acquisition and processing.
  

• Ensure all testing is performed in accordance with SOPs, USP monographs, and GMP regulations.

Investigations, Documentation & CAPA (40%)

• Lead laboratory investigations related to deviations, OOS, OOT, and non-conformances.
  

• Author clear, thorough, and compliant investigation reports, including root cause analysis and corrective actions.
  

• Manage and close CAPAs, ensuring timely and effective resolution.
  

• Perform document review and data verification, ensuring accuracy, completeness, and compliance.
  

• Utilize quality systems such as TrackWise and MasterControl to initiate, track, and lead investigations.
  

• Collaborate cross-functionally with QA, manufacturing, and other departments to resolve quality issues.
  

• Support audit readiness by maintaining well-documented and compliant records.

Additional Responsibilities

• Conduct peer data review and trending analysis to identify potential quality issues.
  

• Assist with calibration, maintenance, and general laboratory operations.
  

• Support continuous improvement initiatives related to laboratory processes and compliance.

Education & Experience

• Bachelor’s degree in Chemistry or related scientific field.
  

• 10–15 years of pharmaceutical QC experience, preferably with oral solid dosage forms and raw materials.
  

• Strong background in GMP-regulated environments and USP testing methods.

Required Skills

• Proven ability to lead investigations (OOS, deviations, CAPAs) from initiation through closure.
  

• Strong technical writing skills, with experience authoring investigation reports and quality documentation.
  

• Hands-on experience with TrackWise and MasterControl, including leading investigations within these systems.
  

• Expertise in analytical instrumentation: HPLC, UPLC, GC, FTIR, Karl Fischer.
  

• Experience with Empower 3 or similar chromatography software.
  

• Strong knowledge of data integrity, documentation practices, and regulatory compliance.
  

• Ability to analyze data, identify root causes, and implement corrective actions.
  

• Excellent organizational, communication, and cross-functional collaboration skills.

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