Senior Associate Quality Control Scientist

Work Location: Verona, Wisconsin
Shift: No
Department: LS-SC-UYWQFB QC Release, VOA
Hiring Manager: Abel Madrigal

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

Your Role:

The Sr Associate QC Scientist 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.

• Conduct analytical testing of cGMP materials (samples, reference standards) and ensure data accuracy using proper techniques and documentation.
• Assist with training new laboratory staff and perform peer reviews.
• Maintain a safe, audit-ready, and clean lab; manage general housekeeping and waste disposal.
• Maintain laboratory supplies and equipment: ordering reagents, ensuring clean glassware, and routine upkeep.
• Solve data-driven problems with evaluation of identifiable factors, exercising judgment within defined procedures.
• Manage projects and timelines with minimal oversight; coordinate with internal groups to keep activities on track.
• Perform instrument Performance Verifications (PV) and manage change controls/CAPAs to ensure on-time completion.
• Support OOS/OOT investigations, SOP writing/revision (raw material, intermediate, final product specs, stability protocols) and ensure compliance with ICH Q7 and 21 CFR parts 11, 210, 211; uphold data integrity.

Physical Attributes:

• Wear appropriate protective gear, (hard hats, glasses/goggles, chemical resistant suits, gloves, safety shoes) and other personal protection equipment "PPE" to protect from toxic or corrosive chemicals in the forms of liquids, solids, vapors or airborne particles

Who You Are

Minimum Qualifications:

• Bachelor's Degree in Chemistry, Biochemistry or other life science discipline.
• 3+ years experience in a GLP or cGMP analytical laboratory environment.

Preferred Qualifications:

• Understanding of 21 CFR Part 11, 210 and 211, and ICH Q7
• 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

Pay Range for this position: $25.00-$39.00 per hour.

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here

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.