Quality Control Scientist 2nd shift

Work Location: Madison, Wisconsin
Shift: Yes
Department: LS-SC-POWQFD QC Release, Weekday Off-Shift
Recruiter: Jennifer Lovell

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

Your Role:

The Scientist, Quality Control Reviewer 2nd Shift role includes the following key accountabilities:

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• Analyze complex and unique issues, applying scientific rationale for root cause analysis and implementing corrective actions.
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• Perform analytical and peer review of cGMP data to ensure accuracy and quality, adhering to ALCOA+ principles.
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• Prioritize in-process control testing review and communicate effectively to minimize manufacturing downtime.
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• Train newer laboratory staff and assist with review of in-process and release testing.
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• Maintain a safe, audit-ready, and clean laboratory by managing supplies and performing general housekeeping.
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• Investigate deviations, identify root causes, and author complex investigations with communication to internal and external customers.
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• Review various reports, including product changeover and method transfer summaries, and manage projects and timelines.
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• Ensure compliance with regulatory requirements (ICH Q7, 21 CFR Parts 11, 210, 211) and agency guidelines (FDA, OSHA, EPA, DNR, DOT).
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• Will work a 2nd shift schedule of 1300 to 2330 Monday-Thursday and travel between Madison and Verona sites as required.
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Physical Attributes:

• Work in analytical testing lab with hazardous and toxic chemicals.

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Who You Are

Minimum Qualifications:

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• Bachelor's Degree in Chemistry, Biology, or other Life Science discipline
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• 5+ years experience in a GMP or GLP setting.
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Preferred Qualifications:

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• Understanding of 21 CFR Part 11, 210 and 211, and ICH Q7.
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• Excellent written and verbal communication skills, as well as good documentation practices and attention to detail.
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• Knowledge and understanding of analytical chemistry techniques.
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• Proficient in LCMSMS analysis.
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• Adequate technical writing skills to author reports, training memos and operating procedures.
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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.