Job Description:
Work Location: Rockville, Maryland
Shift: No
Department: LS-LS-TQOB US Quality Compliance
Recruiter: Genie Hooper
This information is for internals only. Please do not share outside of the organization.
Your Role:
At MilliporeSigma, as the Quality Assurance Specialist 3, you will perform a variety of tasks within the Quality Assurance department including conducting audits and review / approval of various types of regulated documentation.
- Review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers, and other quality records.
- Review and approve study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, cell banking production records, and certificates of analysis.
- Provide support for client regulatory submissions.
- Facilitate client audits, address client concerns and perform supplier audits.
- Review and approve client and supplier quality agreements.
- Review and approve validation files for systems and assays, and deviations / OOS records of varying impact and criticality.
- Conduct trend analysis for deviations and review / approve applicable CAPA records.
- Conduct laboratory inspections to include commissioning and/or internal audits.
- Review and approve client and supplier quality agreements.
- Review and approve change control (GCC) records.
- Provide support for regulatory inspections.
- Lead and/or participate in projects as QA subject matter expert and drive discussions to build consensus across the business regarding Quality topics.
Who You Are:
Minimum Qualifications:
- Bachelor's Degree in a science discipline (e.g., Biology, Chemistry, Biochemistry, etc.), or a Bachelor's Degree in a technical discipline (e.g., Information Technologies, Computer Science, Data Science, etc. )
- 3+ years' experience in Quality Assurance or Quality Control within a GxP environment.
- 2 + years Client and Supplier auditing experience
Preferred Qualifications:
- Acts ethically and ensures quality of own work and that of others.
- Open-minded, flexible and works with agility.
- Takes responsibility for ensuring that turnaround times are met.
- Works with cross-functional teams and builds networks within QA and Operations departments.
- Collaborates with various teams to identify and implement improvements.
- Willing to embrace and implement change on a global scale.
- Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity).
- Excellent communication and interpersonal 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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