Specialist QA 3457411
Title: Specialist QA (Job ID: 3457411)
Location: East Region, Puerto Rico (Open to Puerto Rico Residents who are U.S. Citizens)
Work Model: 100% Onsite – Non-Standard Shift
Contract Type: This position is offered through ProQualityNetwork as a contract assignment supporting our client.
Summary
Our client is seeking a Quality Assurance Specialist to support site quality operations and compliance programs under minimal supervision. The Specialist will perform quality oversight of manufacturing, supply chain, validation, and operational activities to ensure adherence to cGMP, corporate quality standards, and regulatory expectations.
This role requires a highly motivated professional with strong analytical and organizational skills, capable of leading investigations, quality reviews, and audits while ensuring timely and compliant execution of QA responsibilities.
Preferred Qualifications
- Experience in Supply Chain Quality, including incoming sampling and inspection activities.
- Knowledge in warehouse floor quality auditing and operations oversight.
- Proficiency in Smartsheet, Generative AI, Power BI, and SAP.
- Experience initiating and approving Quality Deviations (Nonconformances).
- Availability to work on a Non-Standard Shift schedule.
Key Responsibilities
- Review and approve Master Production (MP) records.
- Approve process validation protocols and reports for manufacturing processes.
- Participate in incident triage as part of the Quality team.
- Approve Environmental Characterization Reports.
- Provide release approval for sanitary utility systems.
- Approve planned incidents and support deviation management.
- Represent Quality Assurance (QA) on new product introduction (NPI) teams.
- Lead and conduct investigations and site audits.
- Own and maintain site quality program procedures.
- Serve as designee for QA Manager on local Change Control Review Boards (CCRB).
- Review and assess risk assessments for quality impact.
- Support automation, facilities, and environmental programs.
- Review and approve work orders, EMS/BMS alarms, nonconformance investigations, and CAPA records.
- Approve and manage change controls.
- Provide lot disposition and authorize final product release for shipment.
Education Requirements
- Doctorate; or
- Master’s degree with 2 years of directly related experience; or
- Bachelor’s degree with 4 years of directly related experience; or
- Associate degree with 8 years of directly related experience; or
- High school diploma/GED with 10 years of directly related experience.
Core Competencies & Skills
- Strong project management and organizational skills.
- Ability to lead cross-functional teams and influence decision-making.
- Advanced knowledge of manufacturing, QA, validation, and process development.
- Experience interacting with regulatory agencies.
- Proficiency in data trending, compliance evaluations, and risk-based assessments.
- Strong written and verbal communication skills in English and Spanish.
- Skilled in Microsoft Office Suite and other data management tools.
- Demonstrated ability to work independently and handle multiple priorities.
- Proven commitment to leadership principles and corporate values.
If you are interested in joining a global leader in biotechnology and contributing to high-quality operations, we invite you to apply through the job description link with your most updated resume for immediate consideration.