Gemini Bioproducts, LLC
Position:
Quality Control ScientistClass:
ExemptReports to:
Quality Validation SpecialistLocation:
On-site, West Sacramento, CA Company ProfileFounded in 1985, GeminiBio serves the global biotechnology industry, from basic research to commercial production, with a focus on helping our customers accelerate the development of life-enhancing biotherapeutics.
The company focuses on producing cell culture products, instruments, and solutions that help customers streamline their discovery, development, and production processes, and by making custom cGMP bioprocess liquids that radically simplify customers' manufacturing workflows - regardless of batch size.
Located in West Sacramento, California, GeminiBio has two manufacturing facilities, comprising a total of 57,000 square feet.
To meet the stringent needs of biotechnology research and production customers, the company's cell culture sera and bioprocess liquid manufacturing facilities are segregated between animal origin-free cGMP manufacturing and animal component cGMP manufacturing.
GeminiBio is an ISO 13485 certified, FDA registered Class 1 Medical Device Manufacturer, aligned with 21 CFR Part 820.
Position SummaryThe Quality Control Scientist position will report to senior leadership within the Quality department.
This position will be a subject matter expert for the assays that are being run within the Quality Control department.
The ideal candidate will perform validation studies on assays and work to optimize assays as needed.
The candidate will craft stability studies and manage the testing and interim and final reports that will go to internal and external customers.
The Quality Control Scientist will take a lead in any investigation pertaining to out of specification that should occur in the quality department.
Good communication skills both written and oral are a must in this position.
Key ResponsibilitiesDesign, create, and implement new processes and procedures within the Quality Control departmentDevelop new analytical methodologies and processes for incoming raw material releaseDevelop and implement specification justifications and associated validation or equivalency justification reportsDevelop, create, and revise new processes and procedures for in-process and final release evaluation criteriaDevelop, create, and implement statistical process control for all testing within the Quality Control departmentTrain Quality Control staff to transfer processes and procedures to routine testing and release processesCreate and manage stability testing protocols, interim and final reports for both GeminiBio products as well as customer productsSupport the Quality Control department as a subject matter expert for analytical testing and processesManage all new analytical or process development activities within the Quality Control departmentEnsure all projects are properly scoped for resources and time and ensures that most up-to-date status is readily availableEnsure all required maintenance procedures are created and documented for any new analytical method or process for use in the QMSEnsure all required documents for an associated analytical or process development activity is properly tracked, stored, and valid for use in the QMSDesign and create IQ/OQ/PQ and calibration protocols within the Quality Control department for analytical equipmentWork and communicates effectively across departments to implement analytical and process improvements within the Quality Control department and to maintain their effectivenessCoordinate with QA and QC management to find resolutions for issues related to laboratory investigationsMaintain thorough knowledge and understanding of all Standard Operating procedures (SOPs) pertaining to testing, review, and equipment calibration and maintenance.
Conscientiously learn requirements of the ISO 13485 quality management system and the achievement of the Company's quality objectivesOther duties as assigned Core CompetenciesCustomer Centric Consistently aware of how work product impacts customer value and experience and works with intensity to optimize customer value and experience.
Able to identify barriers and inefficiencies impacting customer value.
Effective Teamwork Keen ability to collaborate with a diverse set of colleagues - often under pressure - to accomplish business objectives and deliver customer value.
Able to identify - and correct - the issues degrading the success of teams.
Personal LeadershipConsistently delivers high-quality individual results, and when problems are encountered, able to be self-reflective and identify new ways of working to accomplish individual objectives.
Strong level of personal accountability.
Invests time and energy into professional development.
Routinely takes the initiative to solve challenges and capitalize on business opportunities.
Planning and Organizing Able to clearly identify the work that needs to be done and the order in which the work needs to be completed to generate the desired result.
Consistently able to foresee challenges and barriers to success and then effectively develops - and implements - actions to accomplish objectives.
Effective CommunicationsAble to organize thoughts to communicate to colleagues concisely and accurately and, as needed, management.
Oral and written communications are professional and appropriate for the setting and the audience.
Company ValuesIntegrityDoing the right thing - the first time.
Honoring and keeping commitments.
IntensityWorking with speed and focus to deliver the highest quality results - on time.
InvolvementEmbracing unique perspectives and treating others with dignity and respect.
InnovationBiased to improve processes and products to better serve customers and improve workflows.
Required Skills and ExperienceBachelor's degree in Biology, Chemistry, Biochemistry, or a related scientific discipline, and 5
years working in an analytical laboratory role within an ISO-regulated environment Master's Degree in Biology, Chemistry, Biochemistry, or a related scientific discipline, and 3
years in an analytical laboratory role within an ISO-regulated environment Ph.
D.
in Biology, Chemistry, Biochemistry, or a related scientific discipline, and 3
years in an analytical laboratory role within an ISO-regulated environmentDemonstrated experience creating new analytical methods and procedures within a regulated environmentKnowledge and understanding of ISO quality system standards (either ISO 9001 or ISO 13485) required by successfully working within a quality management systemFamiliarity with document control and good documentation practices, and experience creating, writing, revising policies, procedures, work instructions and forms as neededAptitude to work in a complex and rapidly growing companyAbility to develop and deliver communications to provide timely information for actionResults oriented, ensuring targets are met on time and on budgetHave good professional judgment and reliabilityHighly accurate and detail-orientedKnowledge of Microsoft Office productsExperience working with information technology, including database softwareExcellent oral and written communication skillsDemonstrated experience creating IQ/OQ/PQ documentationDemonstrated experience creating new analytical methods or process improvements in a regulated environment is preferredDemonstrated experience managing a multi-faceted project and meeting all required deliverables is preferred.
Certified Lean Six Sigma Green Belt or Black Belt is preferred About the Company:
Gemini Bioproducts, LLC.
Estimated Salary: $20 to $28 per hour based on qualifications.
Quality Control ScientistClass:
ExemptReports to:
Quality Validation SpecialistLocation:
On-site, West Sacramento, CA Company ProfileFounded in 1985, GeminiBio serves the global biotechnology industry, from basic research to commercial production, with a focus on helping our customers accelerate the development of life-enhancing biotherapeutics.
The company focuses on producing cell culture products, instruments, and solutions that help customers streamline their discovery, development, and production processes, and by making custom cGMP bioprocess liquids that radically simplify customers' manufacturing workflows - regardless of batch size.
Located in West Sacramento, California, GeminiBio has two manufacturing facilities, comprising a total of 57,000 square feet.
To meet the stringent needs of biotechnology research and production customers, the company's cell culture sera and bioprocess liquid manufacturing facilities are segregated between animal origin-free cGMP manufacturing and animal component cGMP manufacturing.
GeminiBio is an ISO 13485 certified, FDA registered Class 1 Medical Device Manufacturer, aligned with 21 CFR Part 820.
Position SummaryThe Quality Control Scientist position will report to senior leadership within the Quality department.
This position will be a subject matter expert for the assays that are being run within the Quality Control department.
The ideal candidate will perform validation studies on assays and work to optimize assays as needed.
The candidate will craft stability studies and manage the testing and interim and final reports that will go to internal and external customers.
The Quality Control Scientist will take a lead in any investigation pertaining to out of specification that should occur in the quality department.
Good communication skills both written and oral are a must in this position.
Key ResponsibilitiesDesign, create, and implement new processes and procedures within the Quality Control departmentDevelop new analytical methodologies and processes for incoming raw material releaseDevelop and implement specification justifications and associated validation or equivalency justification reportsDevelop, create, and revise new processes and procedures for in-process and final release evaluation criteriaDevelop, create, and implement statistical process control for all testing within the Quality Control departmentTrain Quality Control staff to transfer processes and procedures to routine testing and release processesCreate and manage stability testing protocols, interim and final reports for both GeminiBio products as well as customer productsSupport the Quality Control department as a subject matter expert for analytical testing and processesManage all new analytical or process development activities within the Quality Control departmentEnsure all projects are properly scoped for resources and time and ensures that most up-to-date status is readily availableEnsure all required maintenance procedures are created and documented for any new analytical method or process for use in the QMSEnsure all required documents for an associated analytical or process development activity is properly tracked, stored, and valid for use in the QMSDesign and create IQ/OQ/PQ and calibration protocols within the Quality Control department for analytical equipmentWork and communicates effectively across departments to implement analytical and process improvements within the Quality Control department and to maintain their effectivenessCoordinate with QA and QC management to find resolutions for issues related to laboratory investigationsMaintain thorough knowledge and understanding of all Standard Operating procedures (SOPs) pertaining to testing, review, and equipment calibration and maintenance.
Conscientiously learn requirements of the ISO 13485 quality management system and the achievement of the Company's quality objectivesOther duties as assigned Core CompetenciesCustomer Centric Consistently aware of how work product impacts customer value and experience and works with intensity to optimize customer value and experience.
Able to identify barriers and inefficiencies impacting customer value.
Effective Teamwork Keen ability to collaborate with a diverse set of colleagues - often under pressure - to accomplish business objectives and deliver customer value.
Able to identify - and correct - the issues degrading the success of teams.
Personal LeadershipConsistently delivers high-quality individual results, and when problems are encountered, able to be self-reflective and identify new ways of working to accomplish individual objectives.
Strong level of personal accountability.
Invests time and energy into professional development.
Routinely takes the initiative to solve challenges and capitalize on business opportunities.
Planning and Organizing Able to clearly identify the work that needs to be done and the order in which the work needs to be completed to generate the desired result.
Consistently able to foresee challenges and barriers to success and then effectively develops - and implements - actions to accomplish objectives.
Effective CommunicationsAble to organize thoughts to communicate to colleagues concisely and accurately and, as needed, management.
Oral and written communications are professional and appropriate for the setting and the audience.
Company ValuesIntegrityDoing the right thing - the first time.
Honoring and keeping commitments.
IntensityWorking with speed and focus to deliver the highest quality results - on time.
InvolvementEmbracing unique perspectives and treating others with dignity and respect.
InnovationBiased to improve processes and products to better serve customers and improve workflows.
Required Skills and ExperienceBachelor's degree in Biology, Chemistry, Biochemistry, or a related scientific discipline, and 5
years working in an analytical laboratory role within an ISO-regulated environment Master's Degree in Biology, Chemistry, Biochemistry, or a related scientific discipline, and 3
years in an analytical laboratory role within an ISO-regulated environment Ph.
D.
in Biology, Chemistry, Biochemistry, or a related scientific discipline, and 3
years in an analytical laboratory role within an ISO-regulated environmentDemonstrated experience creating new analytical methods and procedures within a regulated environmentKnowledge and understanding of ISO quality system standards (either ISO 9001 or ISO 13485) required by successfully working within a quality management systemFamiliarity with document control and good documentation practices, and experience creating, writing, revising policies, procedures, work instructions and forms as neededAptitude to work in a complex and rapidly growing companyAbility to develop and deliver communications to provide timely information for actionResults oriented, ensuring targets are met on time and on budgetHave good professional judgment and reliabilityHighly accurate and detail-orientedKnowledge of Microsoft Office productsExperience working with information technology, including database softwareExcellent oral and written communication skillsDemonstrated experience creating IQ/OQ/PQ documentationDemonstrated experience creating new analytical methods or process improvements in a regulated environment is preferredDemonstrated experience managing a multi-faceted project and meeting all required deliverables is preferred.
Certified Lean Six Sigma Green Belt or Black Belt is preferred About the Company:
Gemini Bioproducts, LLC.
Estimated Salary: $20 to $28 per hour based on qualifications.
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