Quality Enterprises USA
Quality Control Scientist
Quality Enterprises USA, Madison, Wisconsin, us, 53774
Work Location: Madison, WisconsinShift:Department: LS-SC-POWQFD QC Release, Weekday Off-ShiftHiring Manager: Aaron White
This information is for internals only. Please do not share outside of the organization.
Your Role:
The Quality Control Scientist position is responsible for providing technical and analytical leadership to the Quality Control department at MilliporeSigma. Analysis involves the use of HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments. The position demonstrates the ability to work on, and solve, problems independently with some guidance, while also providing technical guidance to less experienced analysts. This position is responsible for writing and revising procedures, specifications, stability protocols, method validations, amongst other documentation.
Other responsibilities may include initiation and review of deviations, OOS/OOT’s, change controls, and CAPA’s. Additionally, participation in process improvement initiatives, working in a team environment, maintaining a clean and safe work area, and supporting the department in maintaining the laboratory in an audit ready state are other duties.
The role may also perform technical review of data as needed.
The Quality Control Scientist position, like all positions at SAFC, will contribute to the overall success of the company by assisting in many areas beyond specific job duties.
This position is a 3rd shift position primarily located at the Verona, WI site. You will be traveling between the Madison, WI and Verona, WI site. Hours of operation are Monday to Thursday from 6:00pm to 4:30am.
Your role:Perform analytical testing cGMP materials (samples, reference standards) and ensure accuracy and quality of data by using proper laboratory techniques and documentationPerform peer reviewsTrain new or less experienced personnel in SOP content, analytical techniques, and instrument useAuthor and revise SOPs including raw material specifications, intermediate specifications, final product specifications, and stability protocolsWork in a safe manner and ensure the lab stays in an audit ready and clean stateMaintain the laboratory by ordering reagents or supplies, ensuring clean glassware is available, disposing of waste properly, and completing general housekeeping choresWork on complex problems in which analysis of data requires an in-depth evaluation of various factorsPerform technical review of data including, but not limited to, HPLC, appearance, KF, and GC for accuracy and qualityExercise judgment within broadly defined procedures and practices to select technique, methods, and evaluation criteria for obtaining resultsSolve problems and make decisions with minimal assistanceMaintain projects and timelines with minimal oversightMeet with internal and external groups to keep projects on trackPerform instrument Performance Verifications (PV) and Operational Qualifications (OQ) as neededManage assigned change controls and CAPAs to ensure on-time completionParticipate in OOS and OOT investigations via testing and good documentation. Apply critical thinking and good problem-solving skills to thoroughly identify root causes and propose appropriate corrective/preventive actions with minimal assistanceWork cooperatively within the QC department and with other departments to achieve project goalsWork in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210, and 211 as applicableSupport all data integrity initiatives and strive for right first timeWho You Are
Minimum Qualifications:
Bachelor’s Degree in Chemistry, Chemical Engineering, or other Life Science discipline5+ years of experience in a GLP or cGMP analytical laboratory environmentPreferred Qualifications:
Thorough understanding of 21 CFR Part 11, 210 and 211, and ICH Q7Excellent written and verbal communication skills, as well as excellent documentation practices and attention to detailAdequate technical writing skills to author reports and operating proceduresAbility to work in analytical testing lab with hazardous and toxic chemicalsKnowledge and understanding of organic analytical chemistry
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
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This information is for internals only. Please do not share outside of the organization.
Your Role:
The Quality Control Scientist position is responsible for providing technical and analytical leadership to the Quality Control department at MilliporeSigma. Analysis involves the use of HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments. The position demonstrates the ability to work on, and solve, problems independently with some guidance, while also providing technical guidance to less experienced analysts. This position is responsible for writing and revising procedures, specifications, stability protocols, method validations, amongst other documentation.
Other responsibilities may include initiation and review of deviations, OOS/OOT’s, change controls, and CAPA’s. Additionally, participation in process improvement initiatives, working in a team environment, maintaining a clean and safe work area, and supporting the department in maintaining the laboratory in an audit ready state are other duties.
The role may also perform technical review of data as needed.
The Quality Control Scientist position, like all positions at SAFC, will contribute to the overall success of the company by assisting in many areas beyond specific job duties.
This position is a 3rd shift position primarily located at the Verona, WI site. You will be traveling between the Madison, WI and Verona, WI site. Hours of operation are Monday to Thursday from 6:00pm to 4:30am.
Your role:Perform analytical testing cGMP materials (samples, reference standards) and ensure accuracy and quality of data by using proper laboratory techniques and documentationPerform peer reviewsTrain new or less experienced personnel in SOP content, analytical techniques, and instrument useAuthor and revise SOPs including raw material specifications, intermediate specifications, final product specifications, and stability protocolsWork in a safe manner and ensure the lab stays in an audit ready and clean stateMaintain the laboratory by ordering reagents or supplies, ensuring clean glassware is available, disposing of waste properly, and completing general housekeeping choresWork on complex problems in which analysis of data requires an in-depth evaluation of various factorsPerform technical review of data including, but not limited to, HPLC, appearance, KF, and GC for accuracy and qualityExercise judgment within broadly defined procedures and practices to select technique, methods, and evaluation criteria for obtaining resultsSolve problems and make decisions with minimal assistanceMaintain projects and timelines with minimal oversightMeet with internal and external groups to keep projects on trackPerform instrument Performance Verifications (PV) and Operational Qualifications (OQ) as neededManage assigned change controls and CAPAs to ensure on-time completionParticipate in OOS and OOT investigations via testing and good documentation. Apply critical thinking and good problem-solving skills to thoroughly identify root causes and propose appropriate corrective/preventive actions with minimal assistanceWork cooperatively within the QC department and with other departments to achieve project goalsWork in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210, and 211 as applicableSupport all data integrity initiatives and strive for right first timeWho You Are
Minimum Qualifications:
Bachelor’s Degree in Chemistry, Chemical Engineering, or other Life Science discipline5+ years of experience in a GLP or cGMP analytical laboratory environmentPreferred Qualifications:
Thorough understanding of 21 CFR Part 11, 210 and 211, and ICH Q7Excellent written and verbal communication skills, as well as excellent documentation practices and attention to detailAdequate technical writing skills to author reports and operating proceduresAbility to work in analytical testing lab with hazardous and toxic chemicalsKnowledge and understanding of organic analytical chemistry
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
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