The Role
Performs on-the-floor plant quality assurance for cGMP manufacturing, including batch records, deviations, CAPAs, change controls, validations, audits, and inspections. Partners cross-functionally with manufacturing, quality, engineering, facilities, and other teams to maintain compliance and product quality. Supports continuous improvement, new product introduction, commissioning and qualification, computer systems validation, data trending, and regulatory interactions. Advises management on quality, compliance, supply, and safety risks while ensuring procedures, training, and documentation requirements are met.
Summary Generated by Built In
• Perform On-the-floor Plant Quality Assurance (PQA) review, approval, and tracking of cGMP processes, procedures, testing methods in manufacturing, documents and records, batch record review, MES, EBR, SAP, EDMQ, DQMS, Trackwise; including but not limited to deviations, CAPAs, and validations.
• Actively engage in continuous improvement initiatives, programs, and projects.
• Vigilantly ensure that changes potentially impacting product quality are assessed according to procedures.
• Certify that deviations from established procedures are investigated and documented per procedures and ensure on-the-floor triage is completed, documented, and current procedural controls are achieved, including ensuring the initiation of deviation records.
• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Require strong collaboration and cross-functional partnership to ensure the Quality Management System, Manufacturing, Process Development, Validation, Quality Control, Warehouse, Engineering, Contractors, Environmental, Facilities, and other processes are executed according to established procedures.
• Serve as a strategic advisor to senior management regarding quality, compliance, supply, and safety risks.
• Support internal/external audits and inspections as part of the audit/inspection management team, including acting as Quality unit representative as needed.
• Accountable for adherence to assigned training, permitting execution of required tasks.
• Champion continuous improvement initiatives and projects.
• Provide support and oversight for New Product Introduction (NPI).
• Demonstrate validated expertise in Quality Systems such as deviations, CAPA, and change control.
• Exhibit experience in computer systems validation or computer systems quality assurance, particularly with medical devices and/or consulting background technical proficiency.
• Possess robust knowledge and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development.
• Experience with validation of GxP applications, including development of Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) protocols, test scripts, and completion/summary report approvals per compliance requirements.
• Validated experience serving as Quality Contact for complex projects involving new products.
• Validated experience in commissioning and qualification.
• Strong organizational skills, including the ability to follow assignments through to completion.
• Enhanced skills in leading, influencing, and negotiating.
• Demonstrate the ability to interact effectively with regulatory agencies.
• Solid word processing, presentation, database, and spreadsheet application skills.
• Strong communication skills in English and Spanish (both written and oral), facilitation, and presentation skills.
• Proven skill in working independently and effectively interacting with all levels throughout the organization.
• Advanced data trending and evaluation abilities.
• Ability to evaluate compliance issues.
Requirements
Bachelor’s degree in Science or Engineering + 4 years of directly related experience
Skills Required
- Bachelor's degree in Science or Engineering
- Four years of directly related experience
- Experience with cGMP manufacturing, distribution, quality assurance, quality systems, and process development
- Experience with deviations, CAPA, change control, and validation processes
- Experience with computer systems validation or computer systems quality assurance
- Experience with medical devices and/or consulting technical proficiency
- Experience validating GxP applications, including validation master plans, IQ, risk assessments, OQ, PQ protocols, test scripts, and summary reports
- Experience serving as a quality contact for complex new-product projects
- Experience with commissioning and qualification
- Strong organizational, leadership, influencing, negotiation, communication, facilitation, and presentation skills
- Ability to communicate in English and Spanish, written and orally
- Ability to interact effectively with regulatory agencies and evaluate compliance issues
- Advanced data trending and evaluation abilities
- Proficiency with word processing, presentation, database, and spreadsheet applications
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The Company
What We Do
ISPV Inc. is a Life Science company that leads Productivity & Validation projects for the Pharmaceutical and Food industries.
