Precision Life Sciences
Our Client is a leading biotechnology company dedicated to advancing scientific research and developing cutting-edge solutions. They are seeking a highly motivated and experienced QC Records Review Consultant with expertise in antibodies to join their team.
As a QC Records Review Consultant with antibody experience, you will play a crucial role in ensuring the quality and compliance of our products and processes. You will be responsible for reviewing and analyzing quality control records, data, and documentation related to antibody production and related processes, and making recommendations for improvements as needed. This role will require someone who is self sufficient and is able to complete what is needed with little oversight and day one.
- Review QC Records: Thoroughly review and analyze quality control records and documentation for antibody production, stability, and characterization, ensuring data accuracy and compliance with relevant standards and regulations.
- Data Analysis: Utilize statistical and data analysis tools to identify trends, anomalies, and deviations in QC records, and provide insights into product quality and process performance.
- Regulatory Compliance: Ensure that all QC records are compliant with industry regulations and company quality standards, and provide guidance on necessary corrective actions when non-compliance is identified.
- Process Improvement: Collaborate with cross-functional teams to identify areas for process improvement and efficiency, recommending changes or adjustments as needed.
- Documentation: Maintain accurate and organized documentation of all QC records and reviews, and assist in the preparation of reports for internal and external stakeholders.
- Troubleshooting: Assist in troubleshooting quality-related issues and participate in investigations to identify root causes and implement corrective and preventive actions.
- Bachelor’s or Master’s degree in a relevant scientific discipline (e.g., biology, biochemistry, immunology, or related field).
- 5-10 years of hands on experience
- Demonstrated experience in quality control and quality assurance, with a focus on antibodies (preferably in a late clinical setting).
- In-depth knowledge of industry standards and regulatory requirements related to antibody production and quality control.
- Strong analytical skills, with proficiency in data analysis and statistical tools.
- Experienced with interactions with a CMO/CTL, including QC release and stability records review and tracking documentation completion
- Will also be responsible for reviewing lab investigations, or owning internal deviations, as needed.
- Preferably also experienced with QC micro methods such as sterility, endotoxin, bioburden
- Excellent organizational and communication skills.
- High proficiency with Adobe Acrobat, Excel, PowerPoint, Word, and Teams
- Smartsheet and Veeva experience a plus
- Ability to work independently and collaboratively in a fast-paced, cross-functional team environment.
- Detail-oriented with a high degree of accuracy and a commitment to data integrity.
- Previous experience in a similar role within the biotechnology or pharmaceutical industry is a plus.
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