Deviation Investigator

Job Description

• Conduct and manage the resolution of deviations, root cause investigations, impact assessments, and CAPAs.
• Liaise with multiple groups and organizations to ensure effective collaboration.
• Proactively manage the progression of investigations and CAPAs to achieve timely closure.
• Lead and participate in cross-functional investigation teams.
• Present investigation findings to key stakeholders and site management.
• Apply Quality Risk Management and Operational Excellence principles to enable risk-based decision-making, drive continuous improvement, and eliminate waste.
• Investigate Quality Control deviations, including Out-of-Specification (OOS) and Out-of-Trend (OOT) results.
• Work collaboratively with all departments and across all organizational levels.
• Take action, make recommendations, and work with minimal supervision while collaborating with management to resolve challenges.
• Work Schedule: Mon- Fri(normal business hours)
  
  

Qualifications

• Required Bachelor's degree in chemical/biochemical engineering, biological sciences, or a related discipline with 2-4 years of relevant experience (or equivalent).
• Prior experience leading cGMP investigations using formal Root Cause Analysis tools required.
• Strong project management skills, including organization, collaboration, multi-tasking, and communication.
• Attention to detail and ability to perform well in a team-based environment.
• Excellent verbal and written communication skills, with the ability to present information clearly and concisely.
• Strong interpersonal and collaboration skills to influence all levels of the organization.
• Familiarity with SOPs, cGMPs, and working within a regulatory environment preferred.
• Knowledge of cell culture, recovery, and/or purification biopharmaceutical manufacturing preferred.
  
  

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.