Sr. Associate Quality Assurance

Mykelly

Juncos (PR)

On-site

USD 34,000 - 48,000

Full time

13 days ago

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Job summary

KellyScience, Engineering, Technology & Telecom (SETT) is seeking a Sr Associate QA for the east region in Puerto Rico. The role focuses on sampling plans, batch record reviews, and QA oversight to ensure compliance with quality standards and GDP guidelines.

The ideal candidate will have a science degree (or masters) with QA experience, strong documentation skills, and fluency in Spanish and English. Will work non-standard shifts, including weekends and holidays, across the facility.

Qualifications

  • Bachelor's degree in Science or Master’s degree with quality experience.
  • Quality experience including sampling plans and batch record review.
  • Experience with deviations, GDP, and data integrity (ALCOA+).
  • Fluent in Spanish and English; able to work all shifts, including weekends.
  • Familiarity with SAP system and electronic batch records.

Responsibilities

  • Perform sampling plans for drug products and batch record reviews.
  • Audit inspection and packaging processes for compliance with procedures.
  • Oversee QA operations, including deviation investigations and change controls.
  • Contribute to SOP revisions to maintain quality standards.

Skills

Spanish
English

Education

Bachelor's degree in Science
Master's degree

Tools

SAP

Job description

At KellyScience, Engineering, Technology & Telecom (SETT), we’re passionate about helping you find a job that works for you. How about this one?We’re seeking for a Sr Associate QAto work in the eastregion, in PR. With us, it’s all about finding the job that’s just right.
Salary: $30.00 p/h

This job might be an outstanding fit if you have:
  • Bachelor’s degree in Science + 6 months of Quality work experienceORMaster’s degree.
  • QA Acceptance Sampling Plan Inspection
  • Execution/documentation in Electronic Batch Record
  • On line Batch Record Review
  • Quality Oversight of the Inspection processes
  • Knowledge of SAP system
  • Experience in batch record review, audit trail reviews and GDP with focus on data integrity (ALCOA+)
  • Experience with deviations.
  • Fluent in Spanish and English.
  • Available to work all shifts- non standard shifts- including weekends, 12hrs shifts, rotate, OT and holidays.

Job summary: The selected individual will perform sampling plans for all drug products, batch record review, audit the inspection and packaging process ensuring compliance to procedures and Quality standards as well as oversee aspects of QA operations within the facility, including but not limited to on-the-floor QA support, deviation investigations, change controls, and SOP revisions.

10443714

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