Work Location: Madison, Wisconsin Shift: No Department: LS-SC-POWQBB QA Operations Madison
Hiring Manager: Dianne Johnson
This information is for internals only. Please do not share outside of the organization.
Your Role:
The Quality Assurance (QA) Senior Associate position at MilliporeSigma in Madison, WI is a critical part of the Quality Assurance Operations (QAO) team and will perform data and batch review, document control and auditing, and support data integrity and root cause analysis. The QA Sr. Associate is responsible for guidance and coaching during operations, as well as assessing and auditing manufacturing processes in real time, providing immediate review with constructive feedback. The ALCOA+ attributes are reinforced by having QA staff on the manufacturing floor. Additional responsibilities include the following:
Act ethically and ensure quality of own work and that of others
Ensure turnaround times are met by working with cross-functional teams and building networks within QA Operations and other departments
Batch review and release
Preparation of documentation for production execution including batch records, supplemental logs, packaging and shipping and other documents in support of cGMP operations
Provide a presence in the Production, Quality Control and warehouse areas to review paper or electronic documentation and to perform line clearances and QA checks
Review batch records in a timely manner to meet committed release dates and ensure documentation is attributable, legible, traceable, permanent, contemporaneously recorded, original and accurate
Prepare certificates of analysis and batch release documentation for accuracy and completion prior to final release of product
Product release through the review of batch documentation
Provide ownership of RFT metrics and QAO KPIs
Conduct internal audits and self-inspection
Support the DI assessment program
Who You Are
Minimum Qualifications:
Bachelor's Degree in Biology, Chemistry, or other Life Science discipline
OR
High School Diploma or GED
3+ years of GMP experience
Preferred Qualifications:
Basic knowledge of FDA regulations (21 CFR Parts 11, 210, 211 etc.)
Experience in Quality Assurance field within a GMP environment
Familiarity with International regulations (EMA, MHRA)
Strong oral and written communication and interpersonal skills
Open-minded, flexible, and capacity to work with agility
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.