Category: Scientific & Clinical
Title: Senior Specialist Quality Assurance - III
Location: West Point, PA
Start date: ASAP
- This position will act as the primary team lead for migration of local test methods and specifications within ExN into QualityDocs and IPI COMET SAP.
- Data migration tasks including checking/harmonizing/cleansing/creating of data as required.
- Perform data migration /conversion of test methods into QualityDocs (Veeva).
- Build data migration /conversion of test specification into Integrated Product Information (IPI) module in COMET SAP.
- Provides SME support for QualityDocs and IPI in COMET SAP.
- Manage the data migration / creation to meet an approved migration plan.
- Managing associated master data through change control processes.
- Provide SME support ensuring data and processes run smoothly with no interruption to supply.
- Establish new or improved processes, tools, and systems and drive consistent, standard business
- Responsible, as needed, for serving on teams when representation is needed related to systems, data, or processes in relevant areas.
- Assure compliance with established policies/procedures of the Division and Corporation and complies with all applicable governmental regulations (GMP, etc.), both domestic and foreign.
- Assist in the preparation and coordination of Senior Management presentations
- Operate in a safe and efficient manner and in compliance with the MMD QO Safety and Health Policy
- Bachelor’s or Master’s Degree (Business, Science, Engineering).
- Desirable evidence of Continuous Professional Development.
- Excellent Excel skills
- Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. manufacturing, quality, engineering, etc).
- At least three years’ experience in the Pharmaceutical industry or a similar operating environment.
- Demonstrated leadership and change management skills with a continuous improvement focus.
- Capability to interact and communicate with all levels of business leadership and operational teams
- Understands data (transfer) and spreadsheet capabilities
- MES (Manufacturing Execution Systems) systems understanding.
- Ability to interact between the business and technical teams
- Technical or data specific capabilities
- Demonstrated use of the Leadership Behaviors
- Demonstrated self-motivation/direction skills with a continuous improvement focus
- Demonstrated successes in a team environment, such as project teams, Advanced PC skills such as Excel, Word, PowerPoint
- Desirable: SAP experience
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.