Tittle: QA Specialist - 35619
Location: Juncos, PR
Important Notice: This opportunity is available only direct individuals' candidates. Third party contractor submissions, staffing, vendors, and Corp-to- Corp (C2C) arrangements will not be considered for this position.
Positions: 1
Work Schedule: Onsite | Administrative Shift - Availability to work different Shifts and/ or weekend or business needs required
Contract Duration: 1 Year
Position Summary
Our client is seeking a QA Specialist to support the site Quality Assurance program with minimal supervision. The selected candidate will provide quality oversight across manufacturing, validation, investigations, compliance, facilities, environmental programs, and other site quality activities within a highly regulated biopharmaceutical environment.
Key Responsibilities
- Review and approve product Manufacturing Procedures (MPs).
- Review and approve process validation protocols and reports for manufacturing processes.
- Serve as the 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 (QA) on New Product Introduction (NPI) teams.
- Lead quality investigations and related activities.
- Lead site audits and support audit readiness activities.
- Own and maintain site Quality program procedures.
- Serve as the QA Manager's designee on the local Change Control Review Board (CCRB).
- Review and evaluate risk assessments.
- Support automation-related quality activities.
- Support facilities and environmental programs.
- Review and approve work orders.
- Review and approve Environmental Monitoring System (EMS) and Building Management System (BMS) alarms.
- Review and approve nonconformance (NC) investigations and CAPA records.
- Review and approve change controls.
- Provide lot disposition and authorize products for shipment.
- Collaborate with cross-functional teams to ensure compliance with applicable quality and regulatory requirements.
Preferred Qualifications
The ideal candidate should have:
- A bachelor's degree in Science, Engineering, Physics, Biology, Chemistry, or a related field.
- Experience working within the biopharmaceutical industry or another highly regulated environment.
- Experience supporting Quality organizations and activities such as:
- Deviation management
- Process validation
- Validation reports
- Equipment and process qualifications
- Quality investigations
- CAPA
- Change controls
- Manufacturing quality systems
- At least 5 years of relevant experience in a highly regulated environment.
Education Requirements
Candidates should meet one of the following educational and experience combinations:
- Doctorate degree; or
- Master's degree + 2 years of directly related experience; or
- Bachelor's degree + 4 years of directly related experience; or
- Associate's degree + 8 years of directly related experience; or
- High school diploma/GED + 10 years of directly related experience.
Core Competencies & Skills
- Strong project management and organizational skills.
- Ability to manage assignments effectively and follow them through to completion.
- Ability to initiate, lead, and coordinate cross-functional teams.
- Strong leadership, influencing, facilitation, and negotiation skills.
- Strong technical knowledge within the relevant area of expertise.
- Ability to collaborate and coordinate effectively with senior-level and external resources.
- Solid knowledge and experience with manufacturing and distribution processes, Quality Assurance, Quality Laboratory functions, validation, and process development.
- Ability to interact effectively with regulatory agencies and support regulatory compliance activities.
- Proficiency with word-processing, presentation, database, and spreadsheet applications.
- Strong written and verbal communication skills.
- Strong facilitation and presentation capabilities.
- Ability to work independently while effectively collaborating with personnel at different organizational levels.
- Advanced data trending, analysis, and evaluation skills.
- Ability to assess compliance issues and determine appropriate quality actions.