Molecular Biologist
2 months ago
Description:
TheQC Analyst, Cell Based Immunology will:
- Perform daily GMP Quality Controllaboratory testing activities at the facility with minimal to noerrors while ensuring testing is completed in compliance with allapplicable procedures, standards, and GMPregulations
- Perform data analysis and finalresult reporting to support product lot release with adherence toturnaround times.
- Perform all activities withrespect to GMP/GDP compliance
- Support thoroughGMP investigations for out of specification test results and otherquality events
- Support technical problemsolving for issues pertaining to GMP QualityControl
- Support product stability programsincluding execution of stability testing, stability data analysisand trending, and final reporting of stabilitydata
- Assist in the generation and revisions ofdocumentation, such as SOP, protocols and reports, deviations,laboratory investigations, CAPAs and changecontrols
- Perform peer review of laboratory dataand logbooks
- Operate at a consistent andexemplary level of efficiency, producing high quality and accurateresults
- Support Health Authorityinspections
- Provide input to functionallaboratory team meetings
- Other responsibilitiesas assigned
Additional Skills& Qualifications:
- Bachelor's degree in arelevant discipline (biological sciences orequivalent).
- Minimum three (3) years ofexperience in the pharmaceutical industry within a Quality Controlrole
- Experience with two or more of thefollowing: Flow Cytometry, Cell based ELISA,NC200
- Successfully interface withmulti-disciplined teams
- Extremelydetail-oriented with strong technicalskills.
- Ability to effectively manage multiplepriorities involving aggressive, changing timelines at a high levelof productivity
- High level of ownership andaccountability
- Demonstrate sense of urgency;ability to recognize timesensitivity
- Proficient with using MicrosoftOffice applications (Outlook, Excel, Word, andPowerPoint)
- Experience with cell therapyproducts
- Shift Sunday throughThursday
AboutActalent
Actalent is a globalleader in engineering and sciences services and talent solutions.We help visionary companies advance their engineering and scienceinitiatives through access to specialized experts who drive scale,innovation and speed to market. With a network of almost 30,000consultants and more than 4,500 clients across the U.S., Canada,Asia and Europe, Actalent serves many of the Fortune500.
Diversity, Equity &Inclusion
At Actalent,diversity and inclusion are a bridge towards the equity and successof our people. DE&I are embedded into our culturethrough:
- Hiring diversetalent
- Maintaining an inclusive environmentthrough persistent self-reflection
- Building aculture of care, engagement, and recognition with clearoutcomes
- Ensuring growth opportunities for ourpeople
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