MilliporeSigma
Quality Control Associate Scientist, Senior
MilliporeSigma, Verona, Wisconsin, United States, 53593
Work Your Magic with us! Start your next chapter and join MilliporeSigma.
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
The Scientist, Quality Associate Senior position is responsible for the cGMP analytical laboratory analysis in the Quality Control department of MilliporeSigma. Analysis may consist of all/some of the following: incoming raw material analysis, in-process testing, final product analysis, method validation/qualification, cleaning, and environmental monitoring to support Quality Control activities at the Madison and Verona sites.
Analysis includes techniques specific to, but not limited to: HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments. 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 Scientist, Quality Associate Senior position will require a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties.
Key Accountabilities:
Perform analytical testing of cGMP materials (samples, reference standards) and ensure accuracy and quality of data by using proper laboratory techniques and documentation.
Assist with training of newer laboratory staff as needed.
Perform peer review.
Work in a safe manner and ensure the lab stays in an audit ready and clean state.
Maintain the laboratory by ordering reagents or supplies, ensuring clean glassware is available, disposing of waste properly, and completing general housekeeping chores.
Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
Exercise judgment within generally defined procedures and practices.
Solve problems and make decisions with minimal assistance.
Maintain projects and timelines with minimal oversight.
Meet with internal project groups to keep projects on track.
Perform instrument Performance Verifications (PV) as needed.
Manage assigned change controls and CAPAs to ensure on-time completion.
Participate in OOS and OOT investigations via testing, good documentation, and assisting with identification of root causes.
Assist with writing and revision of SOPs including raw material specifications, intermediate specifications, final product specifications, and stability protocols.
Work cooperatively within the QC department and with other departments to achieve project goals.
Work in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210, and 211 as applicable.
Support all data integrity initiatives and strive for right first time.
Scope of People Responsibility:
Employee is responsible to adhere to the GMP requirements defined within 21 CFR parts 210 & 211, 820, ICH Q7, Safety standards set under ISO 14001 & 45001.
Physical Attributes:
Regularly sit, stand, walk, reach above the shoulder, stoop, kneel, twist, crouch, or crawl for at least 50% of the day.
Wear appropriate protective gear (hard hats, lab coats, safety glasses/goggles, chemical resistant sleeves, gloves, safety shoes, and half/full face respirators) to protect from toxic or corrosive chemicals in the forms of liquids, solids, vapors, or airborne particles.
Lift and/or move up to 25 pounds unassisted to complete assignments.
Lift more poundage with assistance.
Utilize specific vision requirements including close vision, distance vision, color vision, peripheral vision, depth vision, and the ability to adjust focus.
Location:
Onsite daily at our Verona WI site.
Who You Are:
Minimum Qualifications:
B.S. in Chemistry or similar biological science degree.
3+ years’ experience in a GLP or cGMP analytical laboratory environment, or very similar industry experience.
Preferred Qualifications:
Understanding of 21 CFR Part 11, 210 and 211, and ICH Q7.
5+ years of similar industry experience.
Excellent written and verbal communication skills, as well as good documentation practices and attention to detail.
Knowledge and understanding of analytical chemistry techniques.
Ability to work in analytical testing lab with hazardous and toxic chemicals.
What we offer:
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit
this link .
#J-18808-Ljbffr
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
The Scientist, Quality Associate Senior position is responsible for the cGMP analytical laboratory analysis in the Quality Control department of MilliporeSigma. Analysis may consist of all/some of the following: incoming raw material analysis, in-process testing, final product analysis, method validation/qualification, cleaning, and environmental monitoring to support Quality Control activities at the Madison and Verona sites.
Analysis includes techniques specific to, but not limited to: HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments. 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 Scientist, Quality Associate Senior position will require a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties.
Key Accountabilities:
Perform analytical testing of cGMP materials (samples, reference standards) and ensure accuracy and quality of data by using proper laboratory techniques and documentation.
Assist with training of newer laboratory staff as needed.
Perform peer review.
Work in a safe manner and ensure the lab stays in an audit ready and clean state.
Maintain the laboratory by ordering reagents or supplies, ensuring clean glassware is available, disposing of waste properly, and completing general housekeeping chores.
Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
Exercise judgment within generally defined procedures and practices.
Solve problems and make decisions with minimal assistance.
Maintain projects and timelines with minimal oversight.
Meet with internal project groups to keep projects on track.
Perform instrument Performance Verifications (PV) as needed.
Manage assigned change controls and CAPAs to ensure on-time completion.
Participate in OOS and OOT investigations via testing, good documentation, and assisting with identification of root causes.
Assist with writing and revision of SOPs including raw material specifications, intermediate specifications, final product specifications, and stability protocols.
Work cooperatively within the QC department and with other departments to achieve project goals.
Work in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210, and 211 as applicable.
Support all data integrity initiatives and strive for right first time.
Scope of People Responsibility:
Employee is responsible to adhere to the GMP requirements defined within 21 CFR parts 210 & 211, 820, ICH Q7, Safety standards set under ISO 14001 & 45001.
Physical Attributes:
Regularly sit, stand, walk, reach above the shoulder, stoop, kneel, twist, crouch, or crawl for at least 50% of the day.
Wear appropriate protective gear (hard hats, lab coats, safety glasses/goggles, chemical resistant sleeves, gloves, safety shoes, and half/full face respirators) to protect from toxic or corrosive chemicals in the forms of liquids, solids, vapors, or airborne particles.
Lift and/or move up to 25 pounds unassisted to complete assignments.
Lift more poundage with assistance.
Utilize specific vision requirements including close vision, distance vision, color vision, peripheral vision, depth vision, and the ability to adjust focus.
Location:
Onsite daily at our Verona WI site.
Who You Are:
Minimum Qualifications:
B.S. in Chemistry or similar biological science degree.
3+ years’ experience in a GLP or cGMP analytical laboratory environment, or very similar industry experience.
Preferred Qualifications:
Understanding of 21 CFR Part 11, 210 and 211, and ICH Q7.
5+ years of similar industry experience.
Excellent written and verbal communication skills, as well as good documentation practices and attention to detail.
Knowledge and understanding of analytical chemistry techniques.
Ability to work in analytical testing lab with hazardous and toxic chemicals.
What we offer:
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit
this link .
#J-18808-Ljbffr