Senior Quality Control Analyst
4 weeks ago
The Senior Quality Control Analyst will be responsible for supporting daily lab operations and executing testing activities to support manufacturing, validation, or development studies. The individual will perform a variety of assays using approved or QC technical protocols, ensuring compliance with GMP standards and operational readiness.
Key Responsibilities
- Testing & Analysis: Conduct testing on samples from drug substance and drug product manufacturing, stability studies, and various protocol studies using methods such as SDS-PAGE, QPCR, Potency, Kinetics assay, Enzyme Activity, pH, Osmolarity, A280, etc.
- Quality Control: Maintain GMP readiness of QC areas and ensure operational excellence by adhering to quality standards and protocols.
- Reagent & Inventory Management: Manage and maintain critical reagent inventory, such as antibodies and cell banks, ensuring availability for testing requirements.
- Documentation: Accurately document test results, and manage sample tracking and data entry into LIMS and other systems, maintaining compliance and data integrity.
- Problem Solving: Address testing challenges by applying critical thinking and troubleshooting skills to ensure accurate and reliable test outcomes.
- Compliance & Reporting: Ensure all testing and documentation activities comply with internal policies, SOPs, and external regulatory standards (e.g., FDA).
- Project Participation: Engage in more complex projects and operational excellence initiatives with minimal supervision, providing support for continuous improvement.
- Quality Systems Management: Participate in quality systems activities using tools like SAP and Trackwise for investigations, CAPA, and change controls.
- Sampling & Protocol Support: Assist in sampling activities as needed and provide support in the development and review of QC technical protocols.
- Policy Recommendations: Propose changes to policies and procedures that affect subordinate organizations to optimize QC operations and compliance.
Qualifications
- Education: Bachelor’s degree in a science-related field is preferred.
- Experience: Minimum of 5+ years of related experience in Quality Control.
- Technical Skills: Proficiency in MS Office, LIMS, SAP, and Trackwise.
- Analytical Techniques: Hands-on experience with SDS-PAGE Silver, QPCR, Potency, Kinetics assay, Enzyme Activity, pH, Osmolarity, and other analytical techniques.
- Problem-Solving Skills: Strong analytical skills with the ability to solve complex problems.
- Compliance Knowledge: Full understanding of GMP and industry practices.
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