Sr. Quality Engineer - OQSIE

This position is primarily responsible for supporting the change control within the quality systems organization with focus on QA review and processing of document changes and change controls within the Electronic Document Management Systems (EDMS) and TrackWise system. Additionally, will be Subject Master Expert of the computer systems support Change Control such as EDMS and TrackWise.

1. Provides quality oversight to the change management system for complex Minor and/or Major Change Controls of documents, processes, and systems including managing communication with 3rd party clients pre and post implementation on applicable change controls..
2. This includes verifying that proposed changes adhere to local SOPs and 21 CFR parts 210 and 211 as well as Part 820 requirements while leveraging ICH Q9 and Q10 and ensuring escalation of potential issues to the company management/ 3rd party liaisons.
3. Ensure the health of these systems minimally meet the KPI metrics established by the global team and site leadership by routinely monitoring and managing corrective actions when needed.
4. Become SME for EDMS (the company Doc and Wisdom) and TrackWise for change control and serve as back up other elements within the site's quality systems such as LIMS and SAP.
5. Draft new and revise existing procedures to ensure implementation of continuous improvements/compliance changes related to quality systems processes.
6. Participates in inspection readiness activities, investigations and internal audits with potential to lead investigations.
7. Recognize opportunities for improvement and drive change through collaboration and influencing stakeholders outside quality department and implements continuous improvement efforts as they relate to QA.
8. Solicit information from various departments and compile PowerPoint presentation for routine quality systems meetings
9. Provide employee training for document change and change control processes.
10. Provides guidance to change control owners in all GMP areas to ensure compliance with all applicable procedures / regulations and assists in resolution of issues identified.
11. Maintain work areas and perform job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP's), Standard Operating Procedures (SOP's) and Batch Record instructions.

Requirements:

1. Bachelor's degree required in Science or Engineering.
2. ASQ Certification preferred.
3. 5 years related QA experience in a Pharmaceutical manufacturing environment required.
4. Experience working in a Sterile Aseptic manufacturing environment strongly preferred.
5. Experience with and an in-depth knowledge of cGMP and other applicable industry regulatory requirements related to production of pharmaceutical products and associated quality systems preferred.
6. Experience with and in-depth knowledge of document changes and change control process required.
7. Experience with Manufacturing/Quality systems such as TrackWise EDMS and SAP preferred.
8. Statistical software JMP or Minitab a plus. Experience with a. Strong knowledge of data analysis using MS Excel is preferred
9. Computer proficiency with comprehensive working knowledge of Excel, PowerPoint, and Word required.
10. Detail oriented with ability to identify errors or inconsistencies while performing tasks and to determine or initiate corrective responses around scope of change.
11. Ability to demonstrate sound judgment and decision-making.
12. Experience influencing people with history of achieving results and outstanding outcomes.
13. Ability to build and maintain collaborative relationships between teams, departments and business units. Motivate and influence others without direct authority.
14. Self-directed with ability to organize and prioritize work with little instruction on routine work and under general instructions on new projects.
15. Ability to communicate effectively with excellent written and oral communication skills.

Excellent time management and organization skills to manage small project