BA/BS degree with 4-6 years in a scientific or technical discipline or related QA experience, preferably in sterile product manufacturing.
Knowledge of GxP Compliance, ISO standards, and FDA/EU regulations.
Experience in reviewing/writing change controls and document review for regulatory compliance is preferred.
Strong understanding of GMP quality systems, risk management, and documentation.
Good knowledge of aseptic processing, equipment qualifications, clean rooms, and environmental monitoring is preferred.
Excellent written and verbal communication skills.
Ability to work independently with strong problem-solving and analytical skills.
Responsibilities
Comprehend and interpret GMP, ISO 13485:2016, and EU/FDA regulatory standards.
Serve as the Quality Assurance point of contact on the sterile manufacturing floor.
Review Master Batch Records for compliance and suggest resolutions for identified issues.
Administer Material Review Board transactions and support investigations and CAPAs.
Perform routine visual inspections and ensure adherence to approved batch records and SOPs.
Provide real-time quality oversight during manufacturing and packaging operations.
Initiate and escalate quality events and compliance concerns in a timely manner.
Benefits
Opportunity to work in a dynamic sterile manufacturing environment.
Engagement in critical quality assurance processes for pharmaceutical products.
Collaboration with experienced professionals in the biotech industry.
Potential for career advancement and leadership opportunities.
Involvement in compliance best practices and continuous improvement initiatives.
Full Job Description
Job Summary:
Serve as the primary Quality Assurance representative on the sterile manufacturing floor, providing independent oversight of production operations, ensuring compliance with current GMP requirements, approved batch records, SOPs, and quality systems while supporting the manufacture and release of sterile pharmaceutical products.
Essential Duties:
*Comprehend and interpret GMP, ISO 13485:2016 and EU/FDA regulatory and quality standards.
*Serve as the Quality Assurance point of contact on the sterile manufacturing floor, providing GMP guidance and support for batch record execution, material status, and manufacturing operations for commercial and clinical batches.
*Review Master Batch Records for compliance, identify issues, and suggest possible resolutions.
*Review executed batch records and associated data for compliance to requirements.
*Administer the Material Review Board transactions including accessing the Rework Program.
*Participate in deviation events and investigations as required.
*Support investigations, CAPAs, change controls, and risk assessments related to manufacturing operations.
*Perform data entry and execute records in electronic systems.
*Perform or support the risk management program.
*Identify, communicate and escalate basic technical issues. Identify options for resolutions and lead implementation of corrective actions.
*Prioritize own work and works independently on day-to-day activities, additional supervision/guidance for new assignments.
*Provide guidance/leadership to junior associates.
*Identify and benchmark compliance best practices.
*Perform routine visual inspection and dimensional measurements.
*Observe and verify execution of manufacturing activities in accordance with approved batch records and SOPs.
*Review and approve QA-designated steps within batch records.
*Basic understanding of calibration requirements.
*Ensure appropriate identification, segregation, and status labeling of materials and product throughout manufacturing operations
*Perform line clearance and area clearance verification activities.
*Ensure manufacturing personnel adhere to approved batch records and procedures.
*Responsible for working with MNKD partner relating to their product (e.g. batch record questions, deviations, SOPs, etc.)
*Provide real time quality oversight of manufacturing and packaging operations.
*Support validation/qualification activities for equipment/systems/processes and aseptic process simulations, as required.
*Ensure adherence to approved SOPs, validated processes, and data integrity principles.
*Provide oversight of aseptic operations and critical interventions to ensure compliance with approved procedures and contamination control strategies.
*Provide real-time QA decision making during manufacturing events, process interruptions, and atypical conditions.
*Initiate and escalate quality events, deviations, and potential compliance concerns in a timely manner.
*Responsible for observing all Company, Health, Safety and Environmental guidelines.
Qualifications:
*BA/BS degree 4-6 years in a scientific or technical discipline or related QA experience preferably in the sterile product manufacturing (2-4 years) in pharmaceutical/Biotech industry or the combination equivalent of training and experience.
*Knowledge of GxP Compliance, ISO standards and FDA/EU regulations.
*Experience in reviewing/writing change controls and document review for regulatory compliance is preferred.
*Strong understanding of GMP quality systems, risk management, and documentation
*Good knowledge and understanding of aseptic processing, equipment/utility qualifications, clean rooms and environmental monitoring are preferred.
*Excellent written and verbal communication skills.
*Ability to work independently, demonstrating excellent problem solving and analytical skills.
*Excellent communication skills, both written and verbal and strong interpersonal skills.
(Where reference is made to regulatory environment requirements and/or compliance this includes all applicable regulations i.e. FDA, ISO 13485, European requirements, etc.)
