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Quality Assurance Specialist Job in Miamisburg, Ohio US

Quality Assurance Specialist

Millipore Corporation - Miamisburg, OH

Posted: 7/12/2025 - Expires: 8/11/2025

Job ID: 291596178

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Job Description

Work Location: Miamisburg, Ohio
Shift:
Department: LS-SC-PEMQ Quality Control
Recruiter: Michelle Matthews

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

Your Role:

Support GMP production by performing batch record issuance, review, correction, release, and retention as well as periodic assessments for production lab compliance. Support the site's maintenance, development and improvement of Quality Systems, such as training, CAPA, deviation, change control, and documentation control. Ensure that all aspects of GMP product release meet analytical, production, packaging, and labeling specifications in accordance with established quality systems. Supports the site's compliance activities through regulatory recordkeeping and reporting. Responsibilities and tasks include:

* Ensure product and process consistency through GMP batch record review, deviation reporting, and investigation of anomalies.
* Support and maintain GMP documentation, including procedures, protocols, and specifications.
* Contribute to site compliance by managing quality systems (HR4You, Trackwise, Mango) and reporting site metrics.
* Train and support QA personnel, maintain safety standards, and uphold regulatory and quality policy awareness.
* Collaborate cross-functionally to resolve issues, implement improvements, and drive continuous improvement initiatives.
* Oversee system entries, deliver quality training, and identify process enhancement opportunities.
* Maintain accurate records, meet performance goals, and perform additional duties as assigned.

Who You Are

Minimum Qualifications:

* High School Diploma or GED
* Associates degree in any discipline.
* 2+ years of GMP experience working in an FDA regulated environment.

Preferred Qualifications:

* Bachelor's degree in chemistry, Biology, or other Life Science discipline.
* Experience in high volume and high data environment.
* Knowledge of chemistry with an emphasis on analytical or organic chemistry.
* Knowledge of cGMP, cGLP, cGDP, and ISO 9001 procedures.
* Knowledge of ISO and GMP quality standards.
* Proficient in Microsoft Office Suite.

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.

Apply here: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjEwNTA2LjEwNTA4QGVtZG1pbGxpcG9yZWNvbXAuYXBsaXRyYWsuY29t

Job Summary

Employment Type:
Full Time Employee
Job type:
Regular Employment
Skill Based Partner:
No
Education Level:
No school grade completed
Work Days:
Mon, Tue, Wed, Thu, Fri
Job Reference Code
N/A
Salary
N/A
Licenses / Certifications:
N/A
Display Recommended WorkKeys®Recommended WorkKeys®:
Applied Math: 4
Graphic Literacy: 5

Workplace Documentation: 5