BioSpace
(CW) QC Quality Control Analytical In-Process
BioSpace, Novato, California, United States, 94949
Overview
Join to apply for the
(CW) QC Quality Control Analytical In-Process
role at BioSpace. The Quality Control Analytical In-Process (QCA-IP) Analyst is responsible for performing analytical test methods on in-process intermediates and varying stages of drug products under minimal supervision and within cGMP guidelines, to support further manufacturing of commercial and clinical therapeutics. This is a contract role with shifts that may change due to business needs (Shift 4x10 Sunday-Wednesday; Day (0700-1800) / Swing (1300-0000) or Wednesday-Saturday Day (0700-1800) / Swing (1300-0000)). Pay rate up to $27 per hour. This role may involve knowledge of protein determination by A280, Bradford, and UV Absorbance, enzyme activity, HPLC/UPLC, method validation, and related analytical methods within the scope of quality control and laboratory operations. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assigned. Equal Opportunity Employer/Veterans/Disabled. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Responsibilities
Timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with agreed upon best practices. Execute analytical methods to facilitate in-process testing under applicable cGMP guidelines, and contribute to the prompt reporting of results to meet internal customer timetables. Evaluate completed assay validity, calculate and summarize results, analyze data per expected or specification ranges. Assist with the compilation and verification of trend analysis reports. Perform and collaborate with co-workers to share general housekeeping activities and ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness. Assist with monitoring and control of laboratory supply and critical reagent inventories. Qualify as trainer for specified methods and provide training to less experienced staff. Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures; initiates investigation records within required timeframes. Provide input or assay support to the progression of test method validation, investigations, technical studies, and method transfer protocols. Attend team huddles and department meetings; generate ideas for laboratory infrastructure improvements and method optimization. Perform other responsibilities as deemed necessary. Qualifications
Bachelor of Science degree. 0-3 years of relevant laboratory experience; QC specific experience is preferred. Experience with quality management systems, current Good Manufacturing Practices, and QC principles. Demonstrated working knowledge with respect to certified functional activities. Good documentation, written and verbal communication skills are essential. Must possess the ability to perform most tasks with minimal supervision. Computer literacy required, with proficiency in Microsoft Word and Excel; experience in Microsoft PowerPoint preferred. Must have a quality service attitude and flexibility to work additional hours to meet production or laboratory process requirements. Note: Referrals increase your chances of interviewing at BioSpace.
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Join to apply for the
(CW) QC Quality Control Analytical In-Process
role at BioSpace. The Quality Control Analytical In-Process (QCA-IP) Analyst is responsible for performing analytical test methods on in-process intermediates and varying stages of drug products under minimal supervision and within cGMP guidelines, to support further manufacturing of commercial and clinical therapeutics. This is a contract role with shifts that may change due to business needs (Shift 4x10 Sunday-Wednesday; Day (0700-1800) / Swing (1300-0000) or Wednesday-Saturday Day (0700-1800) / Swing (1300-0000)). Pay rate up to $27 per hour. This role may involve knowledge of protein determination by A280, Bradford, and UV Absorbance, enzyme activity, HPLC/UPLC, method validation, and related analytical methods within the scope of quality control and laboratory operations. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assigned. Equal Opportunity Employer/Veterans/Disabled. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Responsibilities
Timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with agreed upon best practices. Execute analytical methods to facilitate in-process testing under applicable cGMP guidelines, and contribute to the prompt reporting of results to meet internal customer timetables. Evaluate completed assay validity, calculate and summarize results, analyze data per expected or specification ranges. Assist with the compilation and verification of trend analysis reports. Perform and collaborate with co-workers to share general housekeeping activities and ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness. Assist with monitoring and control of laboratory supply and critical reagent inventories. Qualify as trainer for specified methods and provide training to less experienced staff. Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures; initiates investigation records within required timeframes. Provide input or assay support to the progression of test method validation, investigations, technical studies, and method transfer protocols. Attend team huddles and department meetings; generate ideas for laboratory infrastructure improvements and method optimization. Perform other responsibilities as deemed necessary. Qualifications
Bachelor of Science degree. 0-3 years of relevant laboratory experience; QC specific experience is preferred. Experience with quality management systems, current Good Manufacturing Practices, and QC principles. Demonstrated working knowledge with respect to certified functional activities. Good documentation, written and verbal communication skills are essential. Must possess the ability to perform most tasks with minimal supervision. Computer literacy required, with proficiency in Microsoft Word and Excel; experience in Microsoft PowerPoint preferred. Must have a quality service attitude and flexibility to work additional hours to meet production or laboratory process requirements. Note: Referrals increase your chances of interviewing at BioSpace.
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