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Open nowPosted 3 days ago

Specialist QA 35768

inteldot18 open roles

Where
Juncos, Puerto Rico
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Your applicationOpen nowSpecialist QA 35768inteldot · Juncos, Puerto Rico

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  2. 3.5%3 days
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  4. 14.6%14 days
  5. 34.1%30 days
This job: posted 3 days ago

The posting

Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Non-Standard Shift (12 working hours)

Job Description:

Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and quality assurance activities.

Requirements & Qualifications:

  • Perform On-the-floor Plant Quality Assurance (PQA) review, approval, and tracking of cGMP processes, procedures, testing methods in manufacturing, documents and records, batch record review, MES, EBR, SAP, EDMQ, DQMS, Trackwise; including but not limited to deviations, CAPAs, and validations.
  • Actively engage in continuous improvement initiatives, programs, and projects.
  • Vigilantly ensure that changes potentially impacting product quality are assessed according to procedures.
  • Certify that deviations from established procedures are investigated and documented per procedures and ensure on-the-floor triage is completed, documented, and current procedural controls are achieved, including ensuring the initiation of deviation records.
  • Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
  • Require strong collaboration and cross-functional partnership to ensure the Quality Management System, Manufacturing, Process Development, Validation, Quality Control, Warehouse, Engineering, Contractors, Environmental, Facilities, and other processes are executed according to established procedures.
  • Serve as a strategic advisor to senior management regarding quality, compliance, supply, and safety risks.
  • Support internal/external audits and inspections as part of the audit/inspection management team, including acting as Quality unit representative as needed.
  • Accountable for adherence to assigned training, permitting execution of required tasks.
  • Champion continuous improvement initiatives and projects.
  • Provide support and oversight for New Product Introduction (NPI).
  • Demonstrate validated expertise in Quality Systems such as deviations, CAPA, and change control.
  • Exhibit experience in computer systems validation or computer systems quality assurance, particularly with medical devices and/or consulting background technical proficiency.
  • Possess robust knowledge and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development.
  • Experience with validation of GxP applications, including development of Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) protocols, test scripts, and completion/summary report approvals per compliance requirements.
  • Validated experience serving as Quality Contact for complex projects involving new products.
  • Validated experience in commissioning and qualification.
  • Strong organizational skills, including the ability to follow assignments through to completion.
  • Enhanced skills in leading, influencing, and negotiating.
  • Demonstrate the ability to interact effectively with regulatory agencies.
  • Solid word processing, presentation, database, and spreadsheet application skills.
  • Strong communication skills in English and Spanish (both written and oral), facilitation, and presentation skills.

Functions:

  • Review and approve product MPs.
  • Approve process validation protocols and reports for manufacturing processes.
  • Request Quality on incident triage team.
  • Approve Environmental Characterization reports.
  • Release of sanitary utility systems.
  • Approve planned incidents.
  • Represent QA on NPI team.
  • Lead investigations.
  • Lead site audits.
  • Own site quality program procedures.
  • Designee for QA manager on local CCRB.
  • Review Risk Assessments.
  • Support Automation activities.
  • Support facilities and environmental programs.
  • Review and approve Work Orders.
  • Review and approve EMS/BMS alarms.
  • Approve NC investigations and CAPA records.
  • Approve change controls.
  • Provide lot disposition and authorize lots for shipment

Education

  • Bachelor's in science or engineering+ 4 years of directly related experience
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