Location: all cities,NY, USA
Job Description:
Supports the Drug Product Manufacturing Sciences and Technology (DP MSAT) departments through monitoring process performance, data trending, and/or data analysis. Provides support for the design and development of drug product processes and will be part of a team responsible for industrialization, troubleshooting and validation of drug product processes at manufacturing sites, both international and domestic.
Essential Duties and Responsibilities:
Performs verified data entry tasks into electronic systems in a timely and efficient manner.
Tracks cycle time and metrics for data entry process.
Supports the implementation, expansion and continuous improvement of Application for Data Aggregation and reporting system.
Manages quality system events pertaining to data integrity and data management such as investigations, CAPAs, Change Controls and general document approvals.
Trends process performance to establish/improve process capability, uses data analytics to develop metrics and ensures process is operating within intended process control strategy.
Authors policies, technical reports/protocols, change controls, etc. in support of cGMP activities.
Supports/leads efforts associated with the drug product Continued Process Verification (CPV),documentation and trending of In Process Control (IPC) initiative.
Maintains required training status on specific work instructions and SOPs.
Communicates relevant information to peers and teams.
Supports process investigations and assists with product impact assessment for change controlsand internal/external investigations, through data analysis.
Continuously drives to improve processes for improved performance.
Education and Experience:
Requires BS/BA in engineering or scientific discipline or equivalent combination of education and experience.
Experience in a pharmaceutical/biologics cGMP environment or equivalent preferred
Knowledge, Skills, and Abilities:
Ability to work independently or as part of a team.
Ability to communicate with transparency.
Technical knowledge in drug product manufacturing, product development and validation preferred.
Experience with database management preferred.
Experience with data Power BI or similar data visualization software preferred