Nuvexa Scientific, LLC
Job Description
Position Summary
The Quality Assurance Manager is responsible for overseeing and maintaining all quality systems within Nuvexa Scientific’s 503B outsourcing facility in compliance with FDA 21 CFR Parts 210, 211, and 212, USP
/ , and cGMP regulations. This individual ensures that all sterile and non-sterile products are manufactured, tested, and released according to current Good Manufacturing Practices and internal Standard Operating Procedures (SOPs).
Key Responsibilities
Quality Systems Oversight
Develop, implement, and maintain the facility’s Quality Management System (QMS) including Document Control, Deviations, CAPA, OOS/OOT, and Change Control.
Ensure compliance with 21 CFR Part 211, 503B guidance, and FDA inspectional expectations.
Oversee the release of finished drug products and ensure batch record review is performed accurately and timely.
Manage and ensure integrity of Master Batch Records (MBRs) and executed batch production records.
Audits and Inspections
Lead internal audits to verify cGMP compliance and readiness for FDA and State Board inspections.
Act as the primary QA representative during regulatory inspections and third-party audits.
Coordinate supplier and contract manufacturer qualification audits (sterility testing labs, raw material vendors, etc.).
Document Control & Training
Supervise the creation, revision, and approval of SOPs, forms, and controlled documents.
Maintain document lifecycle per cGMP and data integrity (ALCOA+) principles.
Implement and track employee GMP and aseptic technique training programs, maintaining competency records.
Production & Environmental Oversight
Review and approve environmental monitoring (EM), sterility, and particulate monitoring data.
Investigate any excursions in ISO 5/7/8 classified areas and document corrective actions.
Ensure cleanroom qualification, media fills, and aseptic process simulations (APS) meet 503B sterility assurance standards.
Investigations and CAPA
Conduct and document deviation, complaint, and OOS investigations in a timely manner.
Initiate Corrective and Preventive Actions (CAPAs) and verify effectiveness.
Perform trending analysis on deviations, complaints, and EM results to identify systemic issues.
Product Release & Compliance
Review and approve Certificates of Analysis (COAs), Sterility, Endotoxin, and Potency results.
Approve the final disposition of batches (release, reject, or quarantine).
Ensure quality of raw materials, excipients, containers/closures, and labels prior to use.
Qualifications Education: Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemistry, Microbiology, Biology, or related field.
Experience: 5+ years of Quality Assurance experience in pharmaceutical manufacturing or sterile compounding. 2+ years of direct 503B outsourcing or cGMP aseptic manufacturing preferred.
Skills & Competencies: In-depth knowledge of 21 CFR Parts 210/211, FDA 503B guidance, USP
/
/
/
, and ISO 14644. Excellent documentation, organizational, and communication skills.
Physical Requirements Ability to gown and enter ISO-classified areas as needed. Must be able to lift 25 lbs and stand for extended periods when performing audits or cleanroom walkthroughs.
#J-18808-Ljbffr
/ , and cGMP regulations. This individual ensures that all sterile and non-sterile products are manufactured, tested, and released according to current Good Manufacturing Practices and internal Standard Operating Procedures (SOPs).
Key Responsibilities
Quality Systems Oversight
Develop, implement, and maintain the facility’s Quality Management System (QMS) including Document Control, Deviations, CAPA, OOS/OOT, and Change Control.
Ensure compliance with 21 CFR Part 211, 503B guidance, and FDA inspectional expectations.
Oversee the release of finished drug products and ensure batch record review is performed accurately and timely.
Manage and ensure integrity of Master Batch Records (MBRs) and executed batch production records.
Audits and Inspections
Lead internal audits to verify cGMP compliance and readiness for FDA and State Board inspections.
Act as the primary QA representative during regulatory inspections and third-party audits.
Coordinate supplier and contract manufacturer qualification audits (sterility testing labs, raw material vendors, etc.).
Document Control & Training
Supervise the creation, revision, and approval of SOPs, forms, and controlled documents.
Maintain document lifecycle per cGMP and data integrity (ALCOA+) principles.
Implement and track employee GMP and aseptic technique training programs, maintaining competency records.
Production & Environmental Oversight
Review and approve environmental monitoring (EM), sterility, and particulate monitoring data.
Investigate any excursions in ISO 5/7/8 classified areas and document corrective actions.
Ensure cleanroom qualification, media fills, and aseptic process simulations (APS) meet 503B sterility assurance standards.
Investigations and CAPA
Conduct and document deviation, complaint, and OOS investigations in a timely manner.
Initiate Corrective and Preventive Actions (CAPAs) and verify effectiveness.
Perform trending analysis on deviations, complaints, and EM results to identify systemic issues.
Product Release & Compliance
Review and approve Certificates of Analysis (COAs), Sterility, Endotoxin, and Potency results.
Approve the final disposition of batches (release, reject, or quarantine).
Ensure quality of raw materials, excipients, containers/closures, and labels prior to use.
Qualifications Education: Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemistry, Microbiology, Biology, or related field.
Experience: 5+ years of Quality Assurance experience in pharmaceutical manufacturing or sterile compounding. 2+ years of direct 503B outsourcing or cGMP aseptic manufacturing preferred.
Skills & Competencies: In-depth knowledge of 21 CFR Parts 210/211, FDA 503B guidance, USP
/
/
/
, and ISO 14644. Excellent documentation, organizational, and communication skills.
Physical Requirements Ability to gown and enter ISO-classified areas as needed. Must be able to lift 25 lbs and stand for extended periods when performing audits or cleanroom walkthroughs.
#J-18808-Ljbffr