Scientist, Quality (ICP-MS)

Work Location: Verona, Wisconsin
Shift: No
Department: LS-SC-POWQEB QC Project Readiness Team 2
Hiring Manager: Shawn Kotecki

This information is for internals only. Please do not share outside of the organization.

Your Role

MilliporeSigma is seeking a skilled and motivated Analytical Chemist with expertise in Inductively Coupled Plasma Mass Spectrometry (ICP-MS) to support a multidisciplinary CDMO center in Madison/Verona WI. The successful candidate will be responsible for conducting advanced chemical analyses, developing, transferring, and validating analytical methods, and ensuring the accuracy and reliability of test results. The Quality Scientist position, like all positions at SAFC, will require a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties.

• Perform qualitative and quantitative analysis of samples using ICP-MS and microwave digestion.
• Develop, transfer, optimize, and validate analytical methods for trace element analysis.
• Perform analytical testing of cGMP materials (samples, reference standards) and ensure accuracy and quality of data by using proper laboratory techniques and documentation.
• Interpret and report analytical data with a high degree of accuracy.
• Maintain and troubleshoot ICP-MS and digestion instrumentation to ensure optimal performance
• Collaborate with cross-functional teams to support research and development projects
• Ensure compliance with laboratory safety protocols and regulatory standards
• Document and maintain accurate records of all analytical procedures and results
• Provide technical support and training to junior staff and colleagues
• Write, edit, review data and procedures in accordance with cGMP and SOP's
• Participate in Audits and internal/external meetings and author and support change controls
• Ability to work independently and have excellent time management skills
• Perform peer review.
• Train new or less experienced personnel in SOP content, analytical techniques, and instrument use.
• 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 complex problems in which analysis of data requires an in-depth evaluation of various factors.
• Exercise judgment within broadly defined procedures and practices to select technique, methods, and evaluation criteria for obtaining results.
• Solve problems and make decisions with minimal assistance.
• Maintain projects and timelines with minimal oversight.
• Meet with internal and external groups to keep projects on track.
• Perform instrument Performance Verifications (PV) and Operational Qualifications (OQ) as needed.
• Manage assigned change controls and CAPAs to ensure on-time completion.
• Participate 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 assistance.
• Author and revise 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.

Physical Attributes:Ability to work in analytical testing lab with hazardous and toxic chemicals.

Who You Are

Minimum Qualifications:

• Bachelor's Degree in Chemistry, Biology, or other life sciences discipline.
• 3+ years experience in a cGMP analytical laboratory environment, or equivalent industry experience.
• 3+ years of direct ICP-MS analytical method validation experience, or equivalent industry experience.
• 3+ years' experience with microwave digestion sample preparation.

Preferred Qualifications:

• Thorough understanding of USP and
• Excellent written and verbal communication skills, as well as excellent documentation practices and attention to detail.
• Knowledge and understanding of analytical chemistry.
• Advanced technical writing skills to author reports and operating procedures.
• Skilled in operating and maintaining ICP-MS instrumentation (ideally with the Agilent 7800/7850/7900/8900 or similar) with the subsequent data acquisition/processing software (ideally MassHunter 5.2 or similar) and UltraWave microwave digestors
• Strong team player and willing to adapt to changes / be flexible
• Proven problem-solving skills and attention to detail.

RSREMD

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.