Senior Analyst, Manufacturing Process - cGMP Consulting

Responsible for management of Production projects that improve manufacturing efficiency and safety, decrease costs, decrease opportunity for human error, or increase compliance. Works in concert with peers in other departments to meet project timelines. Responsible for tracking the transfer, implementation and monitoring of projects. Uses SAP, LIMS, PI, and other systems, programs and databases to input, verify, monitor and analyze pertinent data. Able to identify opportunities for improvement of manufacturing and business processes. Proposes, plans and facilitates the implementation of improvement solutions. Responsible for inventory maintenance and production tracking.

Responsibilities

• Applies knowledge, experience and technical skills to understand Production objectives, to provide support to Production initiatives, to execute systems and procedures efficiently and compliantly, evaluates systems for improvement potential. Use standard practices to ensure inter-group consistency. Works within established systems to improve Good Manufacturing Practices (GMP) compliance.
• Schedules work tasks, with limited assistance, to support project/campaign timelines. Circulates documents to reviewers with limited assistance, responds to comments and questions. Manages document review and approval to meet project timelines.
• Exercises judgment within generally defined procedures and practices to determine appropriate action. Tracks ongoing problems and gathers information for analysis. Analyze data to develop solutions to general-level problems. Presents a potential solution to management/senior personnel and with assistance creates an implementation plan.
• Assist in the execution of validation activities for the manufacturing equipment. Provide technical assistance related to the manufacturing equipment. Assist in the troubleshooting of the manufacturing equipment.
• Establish requirements and assist in the implementation of changes to the Process Control System.
• Investigates events in production that have quality or compliance impact.  Leads or participates in RCPS or FMEA sessions.  Documents investigation outcomes.
• Transfers methods into Production instructions. Provides training to ensure successful rollout of new methods.
• Responsible for Inventory maintenance and production tracking. Subject matter expert in SAP for inventory and production. Track and report bulk usages. Support production in inventory management. Interface with Planning to create and manage production process order numbers and batch numbers. Initiate and track blanket purchase orders for goods and services to support production. Track weekly and monthly yield performance and report to Department supervision and Finance.
• Frequently interacts with functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects, schedules, etc.
• Comply with company policies and procedures, Engineering Standards and Specifications, Plant procedures, and regulatory agencies regulations and requirements.

Requirements

• Bachelor’s Degree or equivalent required, preferably in an engineering or related field.
• At least 5 years’ experience in all aspects of manufacturing/production processes with good writing skills.
• Experience with OSI Pi data management system.
• A working knowledge of safety, quality systems, and current Good Manufacturing Practices as applied to equipment and process steps in area of responsibility is required. Familiarity with pertinent regulatory filings. Proficiency with tech transfer process and familiarity with equipment and facilities validation
• Must be flexible to handle multiple tasks including ability to handle pressure in a professional manner. Effectively work in a team environment. Maintain high level of energy and professionalism on the job. Build effective working relationships with customers, co-workers, cross-functioned groups, and management.
• Intermediate to High computer and MS Office skills

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