Catalent Pharma Solutions is actively hiring for a Senior Specialist of Quality Systems at our biologics manufacturing site located in Madison, WI. The Quality Assurance department is responsible for all quality assurance and quality control functions at Catalent, Madison. 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 Senior Specialist, Quality Systems role assures that all operations at Catalent meet or exceed cGMP regulations and customer requirements. The Senior Specialist, Quality Systems assures the quality of operations through oversight of investigations, CAPA, change management.
The Role (daily responsibilities)
- Provide oversight to ensure the Quality Systems are maintained in compliance with regulatory and customer requirements.
- Maintains and enhances effectiveness of the Quality System, including identification and implementation of improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Risk Management, and Deviation processes.
- Accountable for the system performance/continuousimprovement/compliance of deviation system. Presents and answers questions about deviation systems and processes to Catalent Management, regulatory inspectors and customers.
- Drives alignment and improvement initiatives, leading cross function teams, to address process improvement, system improvement, and new regulations/expectations.
- Serves as local TrackWise® and ComplianceWire® Subject Matter Expert performing administrative functions for both systems.
- Manages and maintains equipment and controlled document files.
- Reviews and approves all facility and equipment records in support of GMP operations.
- Reviews and approves minor investigations, non-conformances deviations, and change controls in TrackWise®.
- Maintains data integrity and ensure compliance with company SOP’s, specifications; as well as cGMP, ICH, FDA, EMA regulations or guidelines.
- Provides technical assistance and training for personnel.
- Files and maintains controlled documents.
- Other duties as assigned.
The Candidate (requirements)
- Qualified candidate will be hired at the appropriate level (Specialist or Senior Specialist) commensurate with education and years of required elevant experience.
- Master's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of eight years’ related experience in Quality to qualify for the Senior Specialist level; OR
- Bachelor's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science in Quality with minimum of ten years’ related experience to qualify for the Senior Specialist level.
- To qualify for the Specialist level, candidates are required to have a Masters Degree and 6 years of related experience in Quality or a Bachelor's Degree and 8 years of related experience in Quality.
- Experience in cGMP manufacturing, Quality, and Compliance within the pharmaceutical or biotech industry is required. Candidate should have knowledge in equipment or software implementation or validation activities where they have been tasked to perform Quality oversight of related processes. Knowledge of JD Edwards is highly desirable.
- Excellent interpersonal, verbal, and written communication skills with the ability to communicate across all levels of an organization.
- Potential for career growth within an expanding team
- Defined career path and annual performance review and feedback process
- Medical, Dental, Vision and 401K are all offered from Day One of employment
- 19 days of paid time off annually + 7 paid holidays