Cell-Based Immunology Specialist
4 weeks ago
Position Overview:
The Quality Control Analyst in Cell-Based Immunology will be responsible for:
- Conducting daily GMP Quality Control laboratory testing activities at the facility, ensuring minimal errors and compliance with all relevant procedures, standards, and GMP regulations.
- Performing data analysis and final result reporting to facilitate product lot release while adhering to established turnaround times.
- Executing all tasks in accordance with GMP/GDP compliance standards.
- Assisting in comprehensive GMP investigations for out-of-specification test results and other quality-related incidents.
- Providing support for technical problem-solving related to GMP Quality Control issues.
- Contributing to product stability programs, including the execution of stability testing, data analysis, trending, and final reporting of stability results.
- Helping generate and revise documentation such as SOPs, protocols, reports, deviations, laboratory investigations, CAPAs, and change controls.
- Conducting peer reviews of laboratory data and logbooks.
- Maintaining a consistent and exemplary level of efficiency, delivering high-quality and accurate results.
- Supporting Health Authority inspections.
- Offering input during functional laboratory team meetings.
- Undertaking additional responsibilities as assigned.
Required Skills & Qualifications:
- Bachelor's degree in a relevant field (biological sciences or equivalent).
- A minimum of three (3) years of experience in the pharmaceutical industry within a Quality Control capacity.
- Familiarity with two or more of the following techniques: Flow Cytometry, Cell-based ELISA, NC200.
- Ability to effectively collaborate with multi-disciplinary teams.
- Highly detail-oriented with strong technical capabilities.
- Proficient in managing multiple priorities with aggressive, changing timelines while maintaining high productivity.
- Exhibiting a strong sense of ownership and accountability.
- Demonstrating urgency and the ability to recognize time-sensitive situations.
- Proficient in Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
- Experience with cell therapy products is a plus.
- Willingness to work a Sunday through Thursday shift.
About Actalent:
Actalent is a global leader in engineering and scientific services and talent solutions. We assist innovative companies in advancing their engineering and science initiatives by providing access to specialized experts who drive scale, innovation, and speed to market. With a network of nearly 30,000 consultants and over 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many Fortune 500 companies.
Diversity, Equity & Inclusion:
At Actalent, we believe that diversity and inclusion are essential to the equity and success of our workforce. Our commitment to DE&I is reflected in our culture through:
- Recruiting diverse talent.
- Fostering an inclusive environment through ongoing self-reflection.
- Building a culture of care, engagement, and recognition with clear outcomes.
- Providing growth opportunities for our employees.
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