Job Description:
• This individual will work in the Global Quality System & Strategic Transformation organization supporting global projects and initiatives related to Quality Risk Management.
• Activities include all aspects of project management such as leading global projects, creation of deliverables, working with stakeholders and driving technical enhancements.
• The individual will directly work with the Global Quality Risk Management team and be responsible for assessing regulations, developing governance, executing risk documents, and maintaining records.
• This role involves active collaboration with a cross-functional team in manufacturing sites, manufacturing, scientists, supply chain, quality, and other global functions.
• This global function includes monitoring, tracking, and supporting various efforts and initiatives in the Quality System.
• Lead meetings to facilitate and/or support the QRM projects.
• Actively collaborate with a cross-functional team to complete project milestones per established timeline.
• Assist the functional areas on completing the milestones, as needed.
• QA review of the governance or risk document content in compliance with established governing documents.
• Oversee, monitor and track key deliverables associated with project implementation and metrics.
Qualifications:
• Bachelor's degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area.
• Minimum of 5 years of experience in Quality Assurance Specialist
• Project Management experience required.
• Highly motivated and confident facilitating meeting with people from different levels including executives and scientific / technical experts.
• Experience interpretating regulatory documents such as ICH, US / EU and other key GMP regulations to develop risk management governance such as impurities risk assessment, shortage prevention planning, etc.
• Experience working with changes to process or document control and familiar with TrackWise, and Veeva.
• Skills: Result-oriented, strong oral and written communication skills, excellent interpersonal skills, self-starter, attention to details, time management in a fast-paced environment, teamwork, and problem solving.
• Experience with metrics, visualizations for executives / concise & relevant message, and data analytics.
• Experience with automation and developing IT solutions.
• Computer system skills including: Advance or intermediate skills with Microsoft Office suite (e.g. Word, Visio, Power point, Excel, PowerBI, Teams, SharePoint, etc.), TrackWise, and Veeva.
• Highly motivated and confident facilitating meeting with people from different levels including executives and scientific / technical experts.
• Experience working with changes to process or document control and familiar with TrackWise, and Veeva.
• Ability to work independently in a fast-paced environment and managing different projects / tasks.
Benefits:
Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.
