Data Specialist

The Data Specialist is responsible for the collection, statistical analysis and visualization of production data to support the manufacturing team in increasing process performance, robustness and efficiency. The responsibilities of the Data Specialist will include compiling and analyzing data from ongoing and historical manufacturing activities in order to provide actionable information and recommendations to the management team. The Data Specialist will identify and apply appropriate analytical techniques in order to gather data, identify areas of improvement and recommend necessary process controls or other actions to increase process efficiency. They will be working as an individual contributor while reporting to the production department and coordinating with other involved functional areas. The specialist will have a significant impact on manufacturing strategies.

Your Tasks:

• Analyzing selected manufacturing processes, identifying and applying appropriate analytical techniques to gather data, identify areas of improvement, and recommending necessary process controls or other actions to increase process efficiency
• Managing multiple time sensitive projects to deliver targeted outcomes:
• Organizing departmental efforts to identify, prioritize, and assess the impact of process parameters of ongoing manufacturing
• Leading efforts to develop standard data acquisition processes that can be applied to all projects
• Training other team members to perform data analysis
• Identifying causes of variability in multi-stage production processes
• Summarizing analytical results and to effectively communicate recommendations to management
• Utilizing process maps to illustrate manufacturing processes flow
• Defining quality metrics to illustrate the impact of process improvement to customers
• Utilizing trend analysis to identify opportunities for improvement in manufacturing processes
• Coordinate closely with department directors and managers responsible for executing studies
• Present findings to stakeholders using PowerPoint, graphs, charts, etc…
• Ensuring procedures are in full compliance with regulatory requirements
• Supporting company-wide regulatory compliance through compilation of required data to prepare reports for customers and agencies
• Participating in FMEA teams to define process risks
• Supporting Manufacturing departments to draft and review MBPRs, SOPs, deviations, investigations, and other technical documents
• Tracking CAPAs related to the manufacturing department to ensure that commitments are met within established timelines
• Working with the Production team to ensure the production department is in full compliance with the Bachem Quality Management system
• Ensuring all work performed is in compliance with cGMP guidelines
• Maintaining communication with managers, cross-functional teams, and staff
• Report to the VP of Manufacturing on process performance of ongoing manufacturing projects

Required:

• BA/BS in Chemistry, Industrial Hygiene, Pharmacology or related field
• Exposure to reporting tools such as Hyperion/Brio or other higher levels of statistical software
• Minimum of Six years' experience working in a GMP environment
• Experience with statistical analysis applied to pharmaceutical manufacturing
• Understanding of analytical chemistry such as HPLC, LC-MS, GC etc…
• Knowledge of FDA regulations
• Excellent written and oral communication skills
• Expert computer knowledge, including Microsoft Word, Excel, PowerPoint and Project with mastery of spreadsheets and word processing
• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
• Detail oriented with the ability to troubleshoot and resolve technical and analytical problems
• Ability to work independently and manage one's time
• Communicate effectively and ability to function well in a team environment

Preferred:

• Master's Degree
• Experience with project management and oral presentations
• Knowledge of regulatory and ISO standards

Nearest Major Market: Los Angeles