Job Details

ID #20234153
State Florida
City Saintpetersburg
Job type Contract
Salary USD TBD TBD
Source Experis
Showed 2021-09-25
Date 2021-09-25
Deadline 2021-11-23
Category Et cetera
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QA RA Compliance Specialist

Florida, Saintpetersburg, 33701 Saintpetersburg USA

Vacancy expired!

Domain: Pharmaceutical

Job Title: QA Specialist / QC Specialist

Location: St. Petersburg FL

Duration: 06 Months (possibilities of extension)

Description:

  • Main task complaint investigations and annual product reviews Must have Bachelor's in sciences preferred
  • Minitab exp or statistic software is a must Guru skill in Math or excel exp would work as well.
  • Past exp - Medical device complaint or QA Specialist inspector and QC exp transitions well Must have
  • Degree: Chem or math degrees work well but not required 2-3 years exp QC or QA specialist role.
  • This position is responsible for quality and regulatory affairs services, including but not limited to, Drug Master File (DMF) Updates, Health Authority GMP requests, processing and investigating customer product complaints; preparing annual product reviews, tracking and trending, and follow-up of the Change Control and CAPA programs.
  • This position interacts directly with manufacturing, engineering, product development, technical services, validation, etc personnel and is responsible for the quality/regulatory feedback loop to those impacted areas.
  • Preparation and submission of A/NDA submissions (initial, amendments, supplements, annual reports, 15-day Alert Reports); drug master files (initial, amendments, annual reports); plant/site master files; licenses, permits, and registrations to meet FDA and State requirements (especially Florida); other submissions as required
  • Provide regulatory impact assessment on all change controls as required.

Please attach an updated resume of yours.

Arpit Saxena

414-666-8462 ext: 7163

https://www.linkedin.com/in/arpit-saxena-144155b1/

Vacancy expired!

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