Job Description
Job Description
Title: Specialist QA 35471
Location: Juncos, Puerto Rico (Open to Puerto Rico residents)
Work Schedule: Onsite – 3rd Shift
Open Positions: 2
Contract Duration: 5 Months
Position Summary
Our client is seeking a Specialist QA to support Quality Assurance operations under minimal supervision within a highly regulated manufacturing environment. This role is responsible for providing quality oversight to manufacturing operations, leading investigations, reviewing and approving quality documentation, and ensuring compliance with regulatory and internal quality requirements.
The ideal candidate will possess strong experience in quality systems, manufacturing processes, and cross-functional collaboration while demonstrating excellent decision-making, communication, and leadership skills.
Preferred Qualifications
- Experience performing Electronic Batch Record (EBR) review, approval, and reconciliation.
- Experience providing quality oversight to manufacturing operations.
- Strong decision-making and event management skills.
- Experience leading investigations and driving issue resolution in a regulated environment.
Key Responsibilities
- Review and approve product manufacturing procedures (MPs).
- Review and approve process validation protocols and reports for manufacturing processes.
- Participate as a Quality representative on incident triage teams.
- Review and approve Environmental Characterization reports.
- Support the release of sanitary utility systems.
- Review and approve planned incidents.
- Represent Quality Assurance on New Product Introduction (NPI) teams.
- Lead and support investigations related to quality events and non-conformances.
- Lead internal site audits and support continuous improvement initiatives.
- Own and maintain site Quality Program procedures.
- Serve as a designee for the QA Manager on local Change Control Review Boards (CCRB).
- Review and approve Risk Assessments.
- Support automation-related activities.
- Support facilities and environmental programs.
- Review and approve Work Orders.
- Review and approve EMS/BMS alarms.
- Review and approve Non-Conformance (NC) investigations and CAPA records.
- Review and approve Change Control documentation.
- Provide lot disposition decisions and authorize lots for shipment.
- Collaborate and coordinate with higher-level internal and external resources.
- Analyze and trend data to identify opportunities for process improvements and risk mitigation.
- Evaluate compliance issues and recommend appropriate corrective actions.
- Interact effectively with regulatory agencies, as required.
Required Knowledge and Skills
- Strong knowledge and hands-on experience with manufacturing and distribution processes, Quality Assurance (QA), Quality Assurance Laboratory (QAL), validation, and process development activities.
- Demonstrated ability to interact professionally with regulatory agencies.
- Strong proficiency in Microsoft Office applications, including Word, PowerPoint, Excel, and database management tools.
- Excellent written and verbal communication, facilitation, and presentation skills.
- Ability to work independently while effectively collaborating with stakeholders at all organizational levels.
- Strong analytical skills, including advanced data trending and evaluation.
- Ability to assess compliance risks and identify improvement opportunities.
- Strong organizational skills with the ability to manage multiple priorities and complete assignments successfully.
- Experience initiating, leading, and influencing cross-functional teams.
- Strong leadership, negotiation, and decision-making skills.
- Comprehensive knowledge of quality systems and regulated manufacturing environments.
- Demonstrated commitment to leadership principles, accountability, collaboration, and operational excellence.
Education Requirements
- Doctorate degree; OR
- Master's degree and 2 years of directly related experience; OR
- Bachelor's degree and 4 years of directly related experience; OR
- Associate degree and 8 years of directly related experience; OR
- High School Diploma/GED and 10 years of directly related experience.