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Open nowPosted 13 hours ago

Specialist Quality Assurance - Drug Product

Workable (global search)107,691 open roles

Where
Juncos, Puerto Rico
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Your applicationOpen nowSpecialist Quality Assurance - Drug ProductWorkable (global search) · Juncos, Puerto Rico

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8.0% of postings close within 7 days. Measured by our own scanner across the market. Workable (global search) postings stay open a median of 2 days.

Share of postings closed within
  1. 1.6%1 day
  2. 3.6%3 days
  3. 8.0%7 days
  4. 15.0%14 days
  5. 34.2%30 days
This job: posted 13 hours ago

Workable (global search) median: 2 days open

The posting

We are seeking a Specialist Quality Assurance to support the Drug Product Quality Assurance technical team at a biopharmaceutical manufacturing site in Juncos, Puerto Rico. Working under minimal supervision, this role provides Quality oversight of manufacturing, packaging and inspection operations, ensuring compliance with cGMP and site quality procedures.

Key Responsibilities

  • Review and approve master production records, process validation protocols and reports.
  • Represent Quality on incident triage teams and New Product Introduction (NPI) teams.
  • Approve change controls, planned incidents, nonconformance investigations and CAPA records.
  • Lead investigations and site audits; own site quality program procedures.
  • Review risk assessments and support automation, facilities and environmental programs.
  • Review and approve work orders and EMS/BMS alarms; approve environmental characterization reports and release of sanitary utility systems.
  • Act as designee for the QA manager on the local change control review board.
  • Provide lot disposition and authorize lots for shipment.

Requirements

Education (one of the following)

  • Doctorate degree; OR
  • Master's degree + 2 years of directly related experience; OR
  • Bachelor's degree + 4 years of directly related experience; OR
  • Associate's degree + 8 years of directly related experience; OR
  • High school diploma/GED + 10 years of directly related experience

Preferred Qualifications

  • GMP manufacturing experience in Quality Assurance, including review and approval of change controls, deviations, CAPAs, protocols, reports and procedures
  • Experience supporting packaging and/or inspection operations
  • Strong knowledge of Good Documentation Practices (GDP) and electronic quality systems
  • Ability to collaborate effectively with Manufacturing, Engineering and Process Development
  • Bilingual English/Spanish communication skills

Key Skills

  • Project management and strong organizational skills; ability to initiate and lead cross-functional teams
  • Strong knowledge of manufacturing, distribution, QA, validation and process development processes
  • Ability to interact with regulatory agencies and evaluate compliance issues
  • Advanced data trending and evaluation; strong Microsoft Office skills
  • Excellent written and oral communication, facilitation and presentation skills

Benefits

  • Contract position: approximately 5 months (October 2026 – March 2027), with possible extension
  • Shift: Administrative shift
  • Days: Monday to Friday, 8 hours/day (40 hours/week)
  • On-site in Juncos, Puerto Rico
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