QA Specialist (3122582)
Title: Specialist QA (3122582)
Location: Hybrid/Remote Opportunity (Open for Puerto Rico Residents)
Shift: Administrative
Positions Available: 1
Duration: Approximately Four Months
Summary
We are seeking a highly skilled Quality Assurance Specialist to support our client's Quality Assurance program with minimal supervision. The selected candidate will be responsible for various QA functions, including process validation, change control, and new product introduction (NPI).
Preferred Qualifications:
- Experience in New Product Introduction (NPI), validation, and change control.
- Familiarity with DAI processes, PASx/MES applications, risk assessments, MAXIMO, SAP, and LIMS.
- Availability to work weekends as needed.
Key Responsibilities
- Review and approve product Master Plans (MPs).
- Approve process validation protocols and reports for manufacturing processes.
- Act as the Quality representative on the incident triage team.
- Approve Environmental Characterization reports.
- Oversee the release of sanitary utility systems.
- Approve planned incidents.
- Represent QA in New Product Introduction (NPI) teams.
- Lead investigations and site audits.
- Own and manage site quality program procedures.
- Act as a designee for the QA manager on the local Change Control Review Board (CCRB).
- Review and approve Risk Assessments.
- Support Automation activities.
- Assist with facilities and environmental programs.
- Review and approve Work Orders.
- Review and approve EMS/BMS alarms.
- Approve non-conformance (NC) investigations and CAPA records.
- Approve change controls.
- Provide lot disposition and authorize lots for shipment.
Education & Experience Requirements
- Doctorate degree OR
- Master’s degree and 3 years of directly related experience OR
- Bachelor’s degree and 5 years of directly related experience OR
- Associate’s degree and 10 years of directly related experience OR
- High school diploma/GED and 12 years of directly related experience.
Required Competencies & Skills
- Strong project management and organizational skills.
- Ability to initiate and lead cross-functional teams.
- Excellent leadership, influence, and negotiation skills.
- In-depth knowledge of manufacturing, distribution, QA, validation, and process development.
- Strong regulatory compliance understanding and ability to interact with regulatory agencies.
- Proficiency in word processing, presentations, databases, and spreadsheets.
- Excellent written and verbal communication, facilitation, and presentation skills.
- Ability to work independently and interact effectively across all levels of the organization.
- Advanced data trending and evaluation skills.
- Ability to assess and address compliance issues effectively.
If you are a detail-oriented Quality Assurance professional with expertise in regulated industries, we encourage you to apply! Submit your updated resume using the job description link and take the next step in advancing your career.