Job Description
This is a fully benefited role, offering paid time off, holidays, sick leave, vacation, 401(k) match
Looking for a Senior Consultant with over 10 years of experience in the pharmaceutical and biotechnology industry, specializing in Quality Control (QC), Quality Systems, Analytical Method Validation , and Lab Management .
Education Requirement:
bachelor’s degree or higher in Chemistry or a related scientific discipline is required.
Key Responsibilities:
- Oversee and coordinate daily equipment qualifications in QC laboratories, collaborating with cross-functional teams to ensure timely execution.
- Lead analytical method validations , managing project timelines, resource allocation, and testing execution.
- Author and review technical documentation, including SOPs, test methods, validation master plans , and analytical reports in compliance with regulatory requirements.
- Support IQ/OQ/PQ execution, calibration activities , and overall lab readiness in coordination with internal departments.
- Provide oversight for change control processes , including authoring and reviewing documentation in systems such as TrackWise and Veeva Vault Quality Docs .
- Lead the digital transformation of QC systems as Product Owner for Empower CDS
- Manage operations in a high-throughput stability testing lab , leading a team of analysts and implementing Lean Lab and 5S principles to increase productivity and reduce costs.
- Conduct investigations (OOS, deviations) , perform risk assessments and root cause analyses , and implement CAPAs in alignment with cGMP and data integrity standards.
- Oversee data review and documentation compliance , developing and maintaining SOPs to meet evolving regulatory requirements.
- Coordinate stability programs end-to-end, including protocol updates, change control evaluations, and cross-functional collaboration with Regulatory, QA, and Supply Chain.
- Perform hands-on analytical testing for finished products, stability studies, and technical transfer, while reviewing data for regulatory filings and batch release.
- Provide technical leadership for LIMS and electronic data archiving systems , ensuring compliance with FDA and ICH guidelines during audits and inspections.
- Contribute to the creation and maintenance of product specifications for raw materials, APIs, packaging components, and finished products in accordance with USP, ICH , and CFR standards.
Tools & Systems:
- Empower CDS (Waters), TotalChrom
- TrackWise , LIMS , Veeva Vault Quality Docs, ComplianceWire
Key Areas of Expertise:
- Analytical Method Validation & Transfer
- Equipment Qualification (IQ/OQ/PQ); Change Control & CAPA Management
- Stability Program Oversight
- Data Integrity & ALCOA+ Principles
- GMP/GLP Compliance; Regulatory Submissions & Audit Readiness
- Laboratory Operations & Team Leadership
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