The QA Operations Specialist is responsible for quality assurance oversight of manufacturing, testing and supply chain operations with current GMP regulations, procedures and quality systems.
Major Accountabilities
• Provide shopfloor quality oversight of all production, quality control and supply chain departments to ensure their practice fully adheres to cGMP, including data integrity. Ensure timely escalation to management of all applicable incidents.
• Perform live review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.
• Assist functional areas with achieving timely and compliant final product disposition of the product.
• Review, approve and support procedures and production/testing records as required and assist in the training of site associates.
• Ensure compliance of site personnel and application of aseptic techniques and full compliance to sterile manufacturing regulations.
• Support FDA/Regulatory interactions for the Indianapolis site activities and products to ensure successful regulatory submissions and inspections.
• Support QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.
• Other related duties as assigned.
Additional Specifications
• This position involves shift work which will be defined through site business needs.
• Requires flexibility with shifts.
• This position involves on-call shifts, if required, when scheduled.
Key Performance Indicators (KPIs)
• On-time and GMP-compliant release of dosage forms -No complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand -Successfully support continuous improvement projects -Executes batch release in compliance with registration
3. Ideal Background
Education & Qualification
Bachelor's Degree, preferably in Life Sciences, chemistry or related relevant degree.
Language
English
Experiences
2+ years of experience in a GxP Biopharmaceutical manufacturing operations
1+ years of experience in a quality assurance role
• Collaborating across boundaries
• Functional Breadth
• QA and QC experience in biotech pharmaceutical industry with environmental monitoring & cleanliness zones
Competencies
• Continuous Learning (Dyn. Knowledge Development)
• Digital & Technology Savvy
• Operational Excellence
Technical / Function Skills & Knowledge
• Knowledge of GMP and regulations, including FDA regulations (21 CFR Parts 211, 212) and ICH
• • Gmp Procedures.
• QA (Quality Assurance).
• Quality Control (Qc) Testing.
• Quality Standards.
• Self-Awareness.
• Technological Expertise.
• Technological Intelligence.
• Strong organization, communication and presentation skills.
• Excellent and effective interpersonal skills.
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