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Description:
Client is looking for an individual that can come in and help head their chemistry and microbiology lab. Candidate must have experience within the pharmaceutical industry and will be conducting test method development and validations for both chemistry and microbiology tests. Must be able to look at procedures and provide input. They will also be:Develop, validate, and implement pharmaceutical test methods.Serve as a Subject Matter Expert to the company and management in chemistry matters.Conduct analytical chemistry analysis and microbiology (cross training) according to written procedures.Design and conduct statistical analysis to support data analysis.Document lab work according to current good manufacturing and good laboratory and practice requirements.Prepare, review, and publish laboratory procedures.Prepare lab equipment qualifications and validations.Perform QA and QC activities to support operations.Evaluate corrective and preventive actions (CAPA) to ensure an ongoing state of control for chemistry related concerns.Perform lab work, when necessary, examples: HPLC & UHPLC, TOC, LAL, bench testing, Conduct microbiology testing: Environmental Monitoring, sterility testing, bioburden testing.
Skills:
Hplc, sterility testing, Gmp, Chemistry, microbiology, environmental monitoring
Top Skills Details:
Hplc,sterility testing,Gmp
Additional Skills & Qualifications:
Bachelors Degree Hands-on instrument experience and analysis in wet chemistry and HPLC, UHPLC methods. Sterility Testing, Environmental Monitoring, Bioburden Testing Analytical Chemistry techniques, methods, and equipment.Knowledge of FDA current Good Manufacturing Practice and Good Laboratory Practice requirements. ISO/IEC 17025 knowledge and experience a plus.Experience with pharmaceutical Quality Assurance and Quality Control Labs
Experience Level:
Expert Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
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At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
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