Description

Position Summary:

• Establishes compliance standards and designs improvements to internal control structures for operations department.
• Develops compliance organizational strategies by contributing information, analysis, and recommendations to strategic thinking and direction, establishing functional objectives in line with organizational objectives.
• Responsible to assure compliance with FDA regulations in the areas of Non-Conformance Reports (NCR), planned and/or unplanned deviations, and Corrective and Preventive Actions (CAPA) at Nephron Pharmaceuticals Corporation.
• Responsible for assisting with tracking and trending data related to production operations.
• Works alongside other senior managers to develop corporate governance guidelines.
• Assists EVP and VP of manufacturing with long-range operating goals, expansion efforts, and implementation of new and advanced technology.
• Write, update, and develop SOPs, MBRs, or other operational documents with input from daily operational staff and hands-on observations. 
• Execute special projects, like coordinating a series of advisory group calls, organizing a webinar, or compiling and synthesizing information on an issue, as assigned.
• Develop a timeline for the completion of each project.
• Working with production team to manage production workflow, schedule and quality.

Primary Accountabilities: 

• Responsible for conducting through investigations to determine root cause(s), assess potential impact to product, process, or end user, as well as implementation of appropriate corrective and/or preventive actions.
• Works closely with production personnel to develop plans/focus to assure continuous improvements.
• May be cross-trained in other areas in order to succeed in producing quality work, and able to close potential gaps between differing departments identified as part of the investigation process. 
• Monitors production metrics and recommends process improvements, new technologies, and methods to maximize operational efficiency.
• Manages assigned projects by planning, researching, and auditing deliverables.
• Develop and oversee control systems to prevent or deal with violation of legal guidelines and internal policies.
• Revise procedures, reports etc. periodically to identify hidden risks or non-conformity issues.
• Works collaboratively with members of the Production Continuous Improvement Team, as well as the Quality Investigations Team, with attention to repeated occurrences of similar root causes.
• Provide support on the shop floor by observing/assisting in aseptic observations for drug product related processes (i.e. review in-process records, observe media fills, aseptic observation, product/process development work, etc.).
• Ability to adhere to safe work practices and procedures such as aseptic gowning.
• Assists the Production Continuous Improvement Team with the design and development of organizational training programs, tools, and processes to build quality processes.
• Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed. 
• Provide support for multi-departmental investigations, complaints, audit responses, process improvements, and any corrective and/or preventive actions deemed necessary.
• May act as a Subject Matter Expert (SME) based on assigned area of production, training, or background.
• Review the work of colleagues when necessary to identify compliance issues and provide advice or training.
• Keep abreast of regulatory developments within or outside of the company as well as evolving best practices in compliance control.
• Performs additional work duties as assigned or apparent.

Requirements

Knowledge, Skills & Abilities:

NOTE: The primary accountabilities below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

• Bachelor’s degree (or equivalent combination of education and experience) in a related field required.
• 1-2 years project management and coordination experience. 
• 3-5 years of experience in a manufacturing setting; pharmaceuticals manufacturing preferred.
• Lean Six Sigma Certified.
• Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards.
• Must speak, write, and read English.
• Strong interpersonal, problem solving and leadership skills with the ability to lead a team, motivate the group and manager a diverse workplace.
• Action-oriented and eager to drive programs through to completion. Able to deal with pressures and timeline inherent in a fast-paced company.
• An analytical mind able to “see” the complexities of procedures and regulations.
• Demonstrates a strong knowledge of cGMP compliance and regulatory agency requirements and procedures.
• Communication skills, both written and oral, with the ability to collaborate at all levels and functions of the organization.
• Knowledge in Root Cause Analysis Tools and execution.
• Thorough understanding of the policies and practices used in the manufacturing division.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
• Position requires bending, typing, climbing, lifting, reaching, vision (20/20), standing, sitting (60%), walking, and hearing.
• Hours of work: Monday thru Friday on an 8-hour shift, or as needed based on company demands. 
• Salary range: Based on experience