QA Specialist 3081681
Title: Specialist QA 3081681
Location: East of Puerto Rico (Open to Puerto Rico Residents)
Work Schedule: 100% Onsite | Administrative Shift
Summary
Our client is seeking a Specialist QA to support its Quality Assurance program. The selected candidate will perform key duties under minimal supervision, ensuring compliance with Quality Management Systems (QMS) and Good Manufacturing Practices (GMPs) while supporting manufacturing operations.
Preferred Qualifications
Candidates with a scientific and/or engineering background are highly preferred. The ideal candidate must have experience in quality assurance roles focused on QMS and GMP documentation and possess the following:
✅ Must-Have:
- Experience supporting the development and introduction of new equipment/technology, preferably in a Packaging Area.
- Strong knowledge of compliance and regulatory aspects related to equipment validation, operation, and maintenance.
- Expertise in manufacturing documentation systems, including SOPs, Equipment Commissioning & Qualification (protocols, testing, reports, etc.), and the ability to meet deadlines.
- Strong collaboration skills with cross-functional teams, including Manufacturing, Process Owners, Quality, Process Development, and System Owners/Equipment Maintenance.
- Team-oriented mindset with a focus on achieving group objectives.
- Change management and project management skills.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Teams).
✅ Preferred:
- Knowledge of compliance and regulatory aspects of the Devices/Combination Products industry.
- Experience with Veeva, CMMS (Maximo), TrackWise, and similar systems.
- Previous experience working with our client.
Key Responsibilities
The Specialist QA will be responsible for:
- Reviewing and approving Manufacturing Procedures (MPs).
- Approving process validation protocols and reports for manufacturing processes.
- Representing QA in incident triage teams, NPI (New Product Introduction) teams, and site audits.
- Leading and supporting investigations.
- Approving Environmental Characterization reports, planned incidents, non-conformance (NC) investigations, CAPA records, and change controls.
- Providing lot disposition and authorization for shipment.
- Supporting automation, facilities, and environmental programs.
- Reviewing and approving Work Orders and EMS/BMS alarms.
- Owning and managing site quality program procedures.
- Acting as a designee for the QA Manager on the local Change Control Review Board (CCRB).
Education & Experience Requirements
Candidates must meet one of the following criteria:
- Doctorate degree OR
- Master’s degree + 3 years of directly related experience OR
- Bachelor’s degree + 5 years of directly related experience OR
- Associate’s degree + 10 years of directly related experience OR
- High school diploma/GED + 12 years of directly related experience
Required Competencies & Skills
- Project management and organizational skills – Ability to handle multiple assignments efficiently.
- Leadership, influencing, and negotiation skills – Strong ability to lead and collaborate with cross-functional teams.
- Expertise in manufacturing and distribution processes, including QA, validation, and process development.
- Regulatory compliance experience – Ability to interact with regulatory agencies.
- Proficiency in data analysis and trending to evaluate compliance issues.
- Strong communication and presentation skills – Ability to convey technical concepts clearly and effectively.
- Ability to work independently and effectively interact across various levels of the organization.
Why Apply?
This is a fantastic opportunity to advance your career in Quality Assurance within the pharmaceutical industry. If you are a highly skilled professional looking to make an impact in a dynamic and fast-paced environment, we encourage you to apply!
🔗 Submit your updated resume today using the link below: