Janssen Pharmaceuticals, Inc. is actively recruiting for a Senior Quality Assurance Specialist to be based out of Athens, GA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Senior Quality Assurance Specialist will:
- Assure compliance with regulatory requirements and internal company procedures by planning, conducting, reporting quality inspections; internal and external facility evaluations, system audits, and data reviews that support company product releases.
- Provide Quality support to site projects, cGMP systems, and new products.
- Under general supervision, facilitate the QA Department’s daily activities with emphasis on cGMP.
- Assess compliance with cGMP regulations on difficult and complex technical issues.
- Perform batch record review, control record review, and product disposition; including preparation of Certificates of Analysis.
- Coordinate the shipment of final products with Manufacturing and Materials Management.
- Prepare and issue detailed, highly complex reports within the framework of departmental procedures; including QS/QA system reports as required.
- Schedule and lead/participate in internal and external audits; including facility and systems internal audits and inspections.
- Support the execution of cGMP systems aimed at evaluating and maintaining quality and compliance.
- Schedule, lead, and/or participate in the quarterly Site Management Review and documents outcome.
- Perform trending analysis related to quality systems and generate associated reports for quality and site management as required.
- Draft, review, revise, approve, and authorize procedures, work instructions, protocols, validations, specifications, and qualifications.
- Investigate non-conformances as they pertain to the manufacturing and testing of pharmaceuticals and medical devices.
- Drive continuous improvement of site quality systems. Performs gap assessments with quality systems and drug/device master files and ensure compliance.
- Coordinate and perform the drafting of Quality Agreements with suppliers of materials/services and with customers. Will also ensure commitments within approved quality agreements are met.
- A minimum of a Bachelor’s degree (or equivalent degree) in a science or engineering related area is required.
- A minimum 4 years of working knowledge and experience in a cGMP/highly regulated, Quality Assurance and/or Quality Control environment is required.
- Thorough understanding of Quality Systems Regulations, cGMP/GLP regulations, and FDA requirements for pharmaceutical and/or medical devices is required.
- Quality Assurance experience with batch chemical API processes and products; including cGMP batch dispositioning and Q7 knowledge is preferred.
- Experience utilizing statistical analysis for trending data and applying outcomes to process improvements is highly preferred.
- Experience working with TrackWise and other quality systems is a plus.
- This position will be located in Athens, GA and may require up to 5% travel depending on business needs.
Janssen Pharmaceuticals, Inc (6062)Job Function