Bachem Holding AG
Quality Control Scientist
Bachem Holding AG, Vista, California, us, 92085
Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise, Bachem provides products for research, clinical development, and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US, and Asia. The company is listed on the SIX Swiss Exchange. For further information, see
www.bachem.com .A Brief OverviewThe QC Scientist performs laboratory day-to-day operations, guides and interacts with QC and department personnel to accomplish goals and objectives as directed by supervisor. Other duties include performing raw material testing, final product testing, QC documentation, and related GMP activities.What you will doMaintain and perform daily operations of the QC on a daily basis in coordination with the QC Director/Supervisor to include testing of raw material/peptide samples and prioritizing projects.Write and work with other QC Staff and other Departments in the creation and approval of control documents such as specifications, SOPs, STMs, etc.Maintain and perform regular verification of the QC equipment for GMP compliance in coordination with QC Director/Supervisor.Implement and maintain GMP procedures such as following SOP’s, Standard Testing Procedures (STP’s), written procedures, and maintaining proper documentation as necessary for Quality Control.Test, review, and release raw material used in the manufacturing facility for GMP. Performing analytical analysis and reviewing data for completeness and accuracy.Receive, test and release final product peptide manufactured at Bachem.Test and release in-process control samples used in the manufacturing facility for GMP. Performing analytical analysis and reviewing data for completeness and accuracy.Maintain a cGMP quality level of work for the QC operations to include training, documentation, and procedural work.Write/revise specifications as necessary, performing analytical analysis and reviewing data for completeness and accuracy.Write standard operating procedures, standard test procedures, and other related GMP documentation.Perform QC analysis to include: HPLC, UPLC, Water, Mass Spec, UV, GC, melting point, Optical Rotation, TLC, and misc. wet chemistry lab work and other related analytical equipment used for control quality of the GMP facility. This work may include calibration and validation of these methods.Control raw material used in the manufacturing facility for GMP to include receiving, quarantine, testing, and QC release.Investigate any deviation or out of specification as necessary related to QC work performed as instructed by supervisor.Execute validations as necessary to include QC Analytical methods performed, other validations to support the quality of the manufacturing facility.Follow safety guidelines for handling, disposal, and use for a peptide manufacturing company using toxic and/or large volumes of chemicals.Support validation and stability as necessary to include but not limited to analytical work, documentation, and quality GMP procedure.QualificationsBachelor's Degree in Chemistry or related field.Master's Degree in Chemistry or related field (preferred).Minimum of 3 years’ experience in a Quality Control GMP environment.Experience with Peptides (preferred).Technical writing experience (preferred).Experience with Equipment Maintenance Programs (preferred).Use of analytical techniques/instruments, such as HPLC, GC, etc., and computer skills.Excellent written and oral communication skills.Basic computer knowledge, including Microsoft Word, Excel, and PowerPoint.Ability to effectively organize, multitask, and work in a fast-paced, deadline-driven work environment.Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.Detail-oriented with the ability to troubleshoot and resolve problems.Ability to work independently and manage one’s time.Communicate effectively and ability to function well in a team environment.Ability to review Certificate of Analysis for Reagents for the creation of specification documents.Organization skills to support the department in the creation and approval of controlled documents in a timely manner.Flexibility of working hours based on business needs, may include some nights and occasional weekends.Our people are passionate about what they do, the product they sell, and the customers they serve. If you're looking for an opportunity to be a part of a work family that values collaboration, innovation, and dedication, we're the right company for you.Base Hourly Pay Ranges:Quality Control Scientist I: $26.27 - $36.12Quality Control Scientist II: $29.46 - $40.51Quality Control Scientist III: $34.23 - $47.07Sr. Quality Control Scientist: $38.69 - $53.21Placement of new hires in the wage range is based on several factors including education, skill sets, experience, and training.Total RewardsWe offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.Corporate Social ResponsibilityBachem takes responsibility for future generations by careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Platinum Medal status in their assessment of Bachem.Bachem Americas is an Equal Opportunity EmployerAll qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.
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www.bachem.com .A Brief OverviewThe QC Scientist performs laboratory day-to-day operations, guides and interacts with QC and department personnel to accomplish goals and objectives as directed by supervisor. Other duties include performing raw material testing, final product testing, QC documentation, and related GMP activities.What you will doMaintain and perform daily operations of the QC on a daily basis in coordination with the QC Director/Supervisor to include testing of raw material/peptide samples and prioritizing projects.Write and work with other QC Staff and other Departments in the creation and approval of control documents such as specifications, SOPs, STMs, etc.Maintain and perform regular verification of the QC equipment for GMP compliance in coordination with QC Director/Supervisor.Implement and maintain GMP procedures such as following SOP’s, Standard Testing Procedures (STP’s), written procedures, and maintaining proper documentation as necessary for Quality Control.Test, review, and release raw material used in the manufacturing facility for GMP. Performing analytical analysis and reviewing data for completeness and accuracy.Receive, test and release final product peptide manufactured at Bachem.Test and release in-process control samples used in the manufacturing facility for GMP. Performing analytical analysis and reviewing data for completeness and accuracy.Maintain a cGMP quality level of work for the QC operations to include training, documentation, and procedural work.Write/revise specifications as necessary, performing analytical analysis and reviewing data for completeness and accuracy.Write standard operating procedures, standard test procedures, and other related GMP documentation.Perform QC analysis to include: HPLC, UPLC, Water, Mass Spec, UV, GC, melting point, Optical Rotation, TLC, and misc. wet chemistry lab work and other related analytical equipment used for control quality of the GMP facility. This work may include calibration and validation of these methods.Control raw material used in the manufacturing facility for GMP to include receiving, quarantine, testing, and QC release.Investigate any deviation or out of specification as necessary related to QC work performed as instructed by supervisor.Execute validations as necessary to include QC Analytical methods performed, other validations to support the quality of the manufacturing facility.Follow safety guidelines for handling, disposal, and use for a peptide manufacturing company using toxic and/or large volumes of chemicals.Support validation and stability as necessary to include but not limited to analytical work, documentation, and quality GMP procedure.QualificationsBachelor's Degree in Chemistry or related field.Master's Degree in Chemistry or related field (preferred).Minimum of 3 years’ experience in a Quality Control GMP environment.Experience with Peptides (preferred).Technical writing experience (preferred).Experience with Equipment Maintenance Programs (preferred).Use of analytical techniques/instruments, such as HPLC, GC, etc., and computer skills.Excellent written and oral communication skills.Basic computer knowledge, including Microsoft Word, Excel, and PowerPoint.Ability to effectively organize, multitask, and work in a fast-paced, deadline-driven work environment.Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues.Detail-oriented with the ability to troubleshoot and resolve problems.Ability to work independently and manage one’s time.Communicate effectively and ability to function well in a team environment.Ability to review Certificate of Analysis for Reagents for the creation of specification documents.Organization skills to support the department in the creation and approval of controlled documents in a timely manner.Flexibility of working hours based on business needs, may include some nights and occasional weekends.Our people are passionate about what they do, the product they sell, and the customers they serve. If you're looking for an opportunity to be a part of a work family that values collaboration, innovation, and dedication, we're the right company for you.Base Hourly Pay Ranges:Quality Control Scientist I: $26.27 - $36.12Quality Control Scientist II: $29.46 - $40.51Quality Control Scientist III: $34.23 - $47.07Sr. Quality Control Scientist: $38.69 - $53.21Placement of new hires in the wage range is based on several factors including education, skill sets, experience, and training.Total RewardsWe offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.Corporate Social ResponsibilityBachem takes responsibility for future generations by careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Platinum Medal status in their assessment of Bachem.Bachem Americas is an Equal Opportunity EmployerAll qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.
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