Essential Duties and Responsibilities:

• Develops a comprehensive understanding of the manufacturing processes and the associated risk management control strategy to identify process risks and critical controls around the related processing steps.

• Provides consistent direction and timely completion of deviation investigations to ensure ongoing consistency for investigation reports that will stand alone during regulatory inspection through close collaboration with Manufacturing and Quality teams.

• Collaborates with other leaders across the organization and assists in the continuous improvement and life cycle management of implemented GMP policies and quality management systems.

• The investigation owner will lead the investigation of deviations that occur in operations. Author and manage the inquiries to meet key timing commitments with well-investigated and well-documented deviation reports.

• Work with quality assurance, quality control, operations, engineering, maintenance, calibration, safety, and supplier quality management to ensure the appropriate and timely determination of scope, product impact, root cause, and corrective actions.

• Determines scope, product impact, root cause, and corrective actions for procedure deviations. Proposes and implements effective CAPA to eliminate these causes.

• Determines appropriate preventative actions to prevent the reoccurrence of the deviation and author’s deviations and conducts personnel interviews to determine the root cause of the variation.

• Update SOPs or other official documents as required.

• Foster a culture of continuous improvement through employee selection, training, and mentoring while focusing on operational efficiency and eliminating “non-value-added” activities.

• Provide a positive and equitable working environment emphasizing Curia Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.

• Complete any other duties/responsibilities assigned by senior management.

  Supervisory Responsibilities

  This job has no supervisory responsibilities.

  Education and/or Experience:

• Bachelor’s Degree in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy, or equivalent experience with less than one (1) year of related experience. ( Two (2) years of experience equal to one year of education.)

• Experience in a cGMP-regulated manufacturing Pharmaceutical environment and/or QA/QC preferred. Technical writing experience, writing deviations, and CAPAs in the pharmaceutical/biotech industry. Experience with deviation or investigation management systems.

• Relevant industry Biotechnology Manufacturing and/or Quality operations experience. Ability to author and review standard operating procedures, on-the-job-trainings, and other controlled documents. Ability to put complex thoughts and issues into writing so that an educated but uninformed reader can understand and make decisions based on the written investigation report.

• Proficient in Deviation Management (i.e., TrackWise). Experienced in troubleshooting, investigation, and root-cause analysis in a cGMP environment. Proficient in using the following methodology: 5-WHY, Fish-bone diagram, Is and Is-Not, Root Cause Analysis, and Human Error Reduction.

  Language Skills

  Have the ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization.

  Mathematical Skills

  Add, subtract, multiply, and divide into all units of measure using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs .

  Reasoning Ability

  Have the ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Also, deals with problems involving several concrete variables in standardized situations.

  Computer Skills

  To perform this job successfully, an individual should know Spreadsheet and word-processing software.

  Other Skills and Abilities

• Must be able to obtain and maintain gowning certification.

• Must be able to wear a respirator.

• Pass a background check, a drug screen, and a physical.

  Other Qualifications

• Comprehend and follow SOPs, cGMPs, and detailed instructions to successfully produce sterile quality products. Document information, events, and cGMP manufacturing processes, accurately and completely.

• Perform duties in an organized, detail-oriented manner. Work and communicate well with others in a team environment.