Specialist QA 35165

Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Night Shift: 5:00pm-5:30AM

Job Description:

Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and quality assurance activities. 

Responsibilities:

• Review and approve product Master Plans (MPs).
• Approve process validation protocols and reports for manufacturing processes.
• Participate in Quality on Incident Triage Team.
• Approve Environmental Characterization reports.
• Release sanitary utility systems.
• Approve planned incidents.
• Represent QA in the New Product Introduction (NPI) team.
• Lead investigations and site audits.
• Own and maintain site quality program procedures.
• Serve as QA Manager designee on local Change Control Review Board (CCRB).
• Review and assess risk evaluations.
• Support automation activities, facilities, and environmental programs.
• Review and approve Work Orders and EMS/BMS alarms.
• Approve non-conformance (NC) investigations and CAPA records.
• Approve change controls

Job Requirements:

•  Execute Quality disposition (approval or rejection) of bulk drug substances.
• Provide Quality oversight to ensure that operations for clinical and licensed pharmaceutical Drug Substance (API) are manufactured, tested, stored, and managed according to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (cGLP), and other applicable regulations.
• Ensure that deviations from established procedures are identified, reported, and documented per procedures.
• Ensure that changes that could potentially impact drug substance quality are assessed according to procedures.
• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Ensure that facilities, equipment, materials, organization, processes, and procedures align with cGMP practices and other applicable regulations.
• Champion continuous improvement initiatives, programs, and projects, including developing efficiency projects and supervising progress.
• Ensure completion of required training and maintain assigned training adherence to support successful task execution.
• Collaborate and partner cross functionally to ensure the Quality Management System (QMS) processes are completed in accordance with established procedures.
• Support internal and external audits and inspections as part of the audit/inspection management team, including acting as Quality Unit representative as needed.
• Alert senior management of quality, compliance, supply, and safety risks.
• Provide support and oversight for New Product Introduction (NPI).

Preferred qualifications:

•  Expertise in Quality Systems, including Deviations (Nonconformities), CAPA, and Change Control.

• Experience with key electronic systems, such as documentation platforms (e.g., CDOCS), Maximo, TrackWise, LIMS, MES/electronic batch record systems, and SAP.
• Experience in computer systems validation (CSV) or computer systems quality assurance, including consulting level technical proficiency.
• Experience with validation of GxP applications, including Validation Master Plans, GxP risk assessments, IQ/OQ/PQ protocols, test scripts, and summary/approval reports.
• Robust knowledge of manufacturing and distribution processes, including QA, QC, and Process Development operations.
• Validated experience serving as Quality Contact for complex projects involving packaging, inspection, commissioning, qualification, and new drug substances/products.
• Strong organizational skills, with the ability to drive assignments through successful completion. 
• Demonstrated leadership, influencing, and negotiation skills, including interactions with regulatory agencies and evaluation of compliance issues.
• Strong communication skills (written and oral), facilitation abilities, and full bilingual proficiency in English and Spanish, with the ability to work independently and effectively across all organizational levels.

Education & Experience:

• Doctorate degree or master's degree and 2 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment
• or bachelor's degree and 4 years of Quality Manufacturing support experience in pharmaceutical, GMP regulated environment or associate's degree and 8 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment or High school diploma / GED and 10 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment