Deviation QA Associate

Description :

• Responsible for hands on, day-to-day cGMP activities as trained and required per schedule.
• Interact directly with site staff, who are performing the daily operational functions (e.g. manufacturing, QC, etc.), in support of their effort to produce quality products.
• This role ensures that the quality strategy is implemented and that there is a continuous drive to improve product and process quality within the PU, QC labs, and other support area ensure adherence to policies, SOPs, and cGMP requirements.
• Initiation, review and approval of initials and Impact assessment, deviation (with focus on minor and major), quality event and OOS / OOE / OOT investigations and CAPA plan establishment in accordance with applicable SOPs.
• Participates in activities associated with event resolution and CAPAs
• Implements and ensures adherence of appropriate regulations and quality standards.
• Additional activities may be assigned for training and completion as required

Qualifications :

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.