This is a 12-month consulting assignment with the possibility of extension.

Key Duties:

• Injectables experience, strong root cause analysis, and communication
• Have good critical thinking and problem-solving skills (DMAIC, Six Sigma, and Lean).
• Trackwise is a MUST
• GEMBA - good investigational experience who goes to the floor see the actual process where an event occurred and who also implement robust Corrective Actions for the correct Root Causes. - This is Key
• Yellow Belt/Green Belt/Black Belt training/certification preferred.
• Have general knowledge of biotech manufacturing theories and processes.
• Have knowledge of FDA and GXP Regulations, Application of Good Documentation Practices (GDP), and application of current Good Manufacturing Practices (cGMP).
• Be able to support departmental / plant goals.
• Be able to review and approve investigations
• Be able to work independently and with intermittent supervision.

This position is responsible for Quality Manu activities and performs ongoing daily departmental activities tied to Fulfillment. Must be able to handle and manage multiple projects. Demonstrate effectiveness in task completion, decision-making, exception management, training, problem-solving and team leadership. Support or Assist PMT, QWT, Kaizen or equivalent focus type group activities as needed.

Essential Duties and Responsibilities

• Responsible for reviewing and approving pertinent documents, records, and reports such as Manufacturing Batch Records (MBRs), Forms, etc. against Standard Operating Procedures (SOPs), which comprise the majority of the work performed.
• Perform ongoing daily departmental activities related to Product Releases and resolve any issues tied to Product Releases as assigned. Perform the review, approval, and authentication of Product Release Documentation as assigned.
• Responsible for initiating, tracking, investigating, and completing documentation associated with exceptions and corrective actions resulting from the process, equipment, and facility deviations for the areas as needed.
• Serve as a team member and/or assist in CAPA Investigations for significant issues.
• Responsible for Final Review of Events, as needed.
• Assist in the management, technical review, and closure of Product Holds (PH) Associated with protocols related to the analyst’s area of responsibility.
• Manage activities of self in achieving defined Quality goals in an efficient, accurate and timely
• Support in-plant audit-ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO, and Shire quality requirements.
• Support in the development of customer awareness and understanding activities for areas of direct responsibility and, where appropriate, assist and support such activities throughout the facility.
• Support for Internal and External Quality audits/assessments and provide ongoing feedback related to quality issues.
• Support and drive continuous improvements consistent with the divisional strategy and ensure compliance with all applicable state, federal and international regulations.
• Administer and maintain relevant databases, preparing and issuing reports as defined by the area as well as developing custom reports as needed.
• Must demonstrate strong leadership, influence, and cross-functional collaboration skills and be able to work efficiently in a cross-functional team environment.
• Represent department in cross-function projects
• Skilled in use of electronic word processing, spreadsheet, project management, and presentation tools such as Microsoft Office (Word, Excel, Project, PowerPoint).
• Ability to prioritize and thrive in a fast-paced environment.
• May perform other duties as assigned.

Qualifications

• Have strong interpersonal skills
• Have the ability to operate in a dynamic, cross-functional environment.
• Be able to be flexible.
• Result Driven- manufacturing process simplification and also yield improvement ideas, generate breakthrough solutions.
• Being able to have great attention to detail is necessary.
• Be able to handle multiple tasks and projects concurrently
• Have strong organizational skills and the ability to plan, follow up, and implement tasks.

Job Type: Contract