Quality Assurance Specialist 2
Millipore Corporation

Work Location: Norwood, Ohio
Shift: Yes
Department: LS-SC-PENQA Quality Assurance
Hiring Manager: Geoffrey Neller

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

Your Role

As the Quality Assurance Specialist 2 at MilliporeSigma in Norwood, OH, you are a key contributing team member of the Quality Assurance team behind the site's alignment to the ISO 9001:2015 Quality Management System (QMS) standard. Your role requires attention to detail, thoroughness, and communication skills as you administer the electronic Quality Records system on the site to ensure that records are entered, processed, and completed in a timely manner (within defined due dates). Daily tasks include the following:

• Owns the customer complaint process and working with customers, Product Managers, Account Managers, Technical Services, and Customer Services to investigate and process complaints in a timely and thorough manner.
• Acts as the Site Lead User for all modules of the TrackWise electronic quality record system (Complaint, Change Control, Audit, CAPA, Deviation, RCA).
• Ensures records in all modules are entered, processed, and completed in a timely manner and within due dates.
• Coordinates external audits and assists the QA Supervisor in conducting Internal QMS audits, as well as other activities as needed/defined by the QA Supervisor and/or the Quality Manager.
• Maintains and analyzes complaint-related metrics and holds monthly complaint meetings.
• Ensures critical investigations are completed successfully and according to established protocols; leads or assists in conducting in-depth analyses of out-of-specification (OOS), Corrective and Preventive Action (CAPA), Complaint, Deviation, Change Controls, and Root Cause Analysis (RCA).
• Provides QA support for Distribution quality issues and initiatives.
• Works with the QA team to write, review, and approve Operating Procedures, Work Instructions, and Forms for the QA group.
• Monitors the production floor, QC labs, and DC warehouses for any quality-related issues, taking prompt action and collaborating closely with stakeholders to swiftly resolve issues.
• Leads or assists (as applicable) process improvement initiatives and projects, leveraging your expertise to drive continuous improvement of quality-related practices, methods, and systems.
• Monitors LS monthly metrics (Heatmap, QIP's, Global Documents, IMR and Supplier reviews).

Who you are:

Minimum Qualifications:

• Bachelor's Degree in a Life Sciences (e.g., Chemistry, Pharmacy, etc.) or Engineering (e.g. Chemical Engineering, Mechanical Engineering, etc.) discipline.
• 3+ years of work experience in a QA function.

Preferred Qualifications:

• ISO 9001 Lead Auditor.
• 2+ years of customer facing experience.
• TrackWise and SAP experience.
• Complaint processing experience.
• Experience communicating across all levels of an organization.
• Report writing skills.
• Knowledge of GDP/GMP methods and processes.
• Ability to multiple projects/tasks/priorities simultaneously.
• Excellent problem-solving skills.
• Knowledge of data analysis, presentation, and experimental design.
• Excellent computer skills.

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.

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