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Sr. QA Specialist 33141 - 2029912

Title: Sr. Specialist QA 33141 (Pharmaceutical/Biotech Industry) 🌟

🏢 Hybrid/Virtual/Remote Opportunity for Administrative Shifts

⏳ Period: 2 1/2 years Contract with ProQuality Network


Preferred Qualifications:

  • Experience in change control, nonconformance review, preventive maintenance review, minor deviations, work orders, and job plans.


SUMMARY

In support of our client's Quality Assurance program, we are seeking a highly skilled Sr. Specialist QA. This role involves acting as a technical specialist, reviewing and approving product Master Plans.


FUNCTIONS

  • Approve process validation protocols and reports for manufacturing processes.
  • Represent Quality on incident triage team.
  • Approve Environmental Characterization reports.
  • Release sanitary utility systems.
  • Approve planned incidents.
  • Represent QA on NPI team.
  • Lead investigations.
  • Own site quality program procedures.
  • Designee for QA manager on local CCRB.


EDUCATION/LICENSES

  • Doctorate degree and 2 years of directly related experience
  • Master's degree and 6 years of directly related experience
  • Bachelor's degree and 8 years of directly related experience
  • Associate's degree and 10 years of directly related experience
  • High school diploma/GED and 12 years of directly related experience


COMPETENCIES/SKILLS

  • Project management skills.
  • Strong organizational skills, including ability to follow assignments through to completion.
  • Initiate and lead cross-functional teams.
  • Enhanced skills in leading, influencing, and negotiating.
  • Strong knowledge in area of expertise.
  • Collaborate and coordinate with higher-level outside resources.
  • Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and processes development.
  • Demonstrated ability to interact with regulatory agencies.
  • Strong word processing, presentation, database, and spreadsheet application skills.
  • Strong communication (both written and oral), facilitation, and presentation skills.
  • Strong skill in working independently and effectively interacting with various levels.
  • Advanced data trending and evaluation.
  • Ability to evaluate compliance issues.
  • Demonstrate the client's Values/Leadership Practices.


If you are interested in this exciting opportunity, please send your updated resume to careers@proqualitynet.com with the subject line "Sr. QA Specialist 33141". Join us in making a difference in the pharmaceutical and biotech industry! 🚀🔬💼


Thank you. We will be in contact soon.

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