Catalent is currently seeking a Specialist, Quality Assurance Operations for the biologics manufacturing site in Madison, WI. The Quality Assurance department is responsible for all quality assurance and quality control functions at Catalent Madison Biologics site. The Department’s primary function is to ensure compliance with FDA and other regulatory agency requirements, as well as internal quality systems requirements for the facility. This includes project review for accuracy and compliance, systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, and raw material, Master Cell Bank, and API release.
The QA Operations Specialist assures that all operations at Catalent meet or exceed cGMP regulations and client customer requirements. The QA Operations Specialist assures the quality of Cell Banks and Bulk Drug Substance produced and supports release of BDS for further clinical manufacturing of drug product. This position also ensures quality of manufacturing and laboratory data and reports. This is accomplished by direct collaboration and oversight of Manufacturing Operations and Quality Control and the review/audit of data and reports as specified by Standard Operating Procedures. The position is for a Monday through Friday, 2nd shift schedule which is 3:00 PM to 11:30 PM.
The Role (daily responsibilities)
- Serves as ‘Quality on the floor’ to assist and support manufacturing staff in detecting and solving compliance errors in real time.
- Audits GMP areas including during production.
- Reviews batch records, QC testing records, and all supporting records.
- Issues manufacturing batch records and labels.
- Reviews and approves ancillary facility and equipment records in support of GMP operations.
- Reviews and approves assay qualification, equipment, and stability protocols.
- Maintains and enhances effectiveness of the Quality System.
- Establish and track key metrics
- Compiles complete batch records through collection of documentation from multiple sources (production, labs, etc.).
- Identifies and drives resolution of all documentation and batch record issues to allow for timely release.
- Assures final drug products are manufactured and tested in a manner consistent with the applicable regulatory or client requirements.
- Performs final approval and release of product for shipment to customers
- Provides technical assistance and training for personnel.
- Files and maintains controlled documents.
- Other duties as assigned.
The Candidate (requirements)
- Bachelor's Degree in technical or scientific discipline (e.g. biology, biotechnology, engineering) with minimum of 7 years’ related experience. Master's Degree in technical or scientific discipline (e.g. biology, biotechnology, engineering) with minimum of 4 years’ related experience
- Ability to use Excel, Word, and other office systems.
- Understand and independently apply GMPs to everyday work with regard to documentation and review.
- Understanding and adherence to applicable regulatory authority and guidelines.
- Demonstrates theoretical understanding of the work tasks assigned.
- Ability to operate within a clean room environment as needed.
- Maintains high quality documentation in accordance with applicable regulatory guidance and Site SOPs.
- Prior work experience with quality management software preferred (e.g. TrackWise®, ComplianceWire®, or similar applications).
- Ability to learn, retain, and apply technical information on multiple topics.
- Develop and execute complex procedures with high quality.
- Understanding of pharmaceutical laboratory and / or production operations.
- Ability to complete investigation, deviation, and change control forms independently.
- Capable of rapid learning of unfamiliar principles or techniques with minimum training.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Authors, edits and reviews Standard Operating Procedures (SOPs), Batch Production Records (BPRs), and reports.
- Ability to problem solve to initiate and execute/monitor corrective action.
- Ability to independently interpret data, analyze trends and provide insight into potential issues and subsequent solutions.
- Mathematical and scientific reasoning ability.
- Familiar with quality risk management, regulations and their context.
- Knowledge of cGMP, ICH, FDA, EMA regulations or guidelines.
- Good working knowledge of quality systems and risk management.
- Ability to formulate complex and comprehensive materials such as authoritative reports and/or to create/deliver formal and informal presentations.
- Hands on experience with Risk Assessment (especially Hazard Analysis, Fault Tree Analysis, FMEA, etc.).
- Functional understanding of the FDA Drug Development Cycle.
- Demonstrated ability to understand and relay/incorporate expertise given from technical staff outside their area of expertise to their program.
- Ability to assist in technical calls for departmental projects as well as discussions regarding investigations or other issues.
- Recognize unmet customer and / or regulatory needs.