Quality Assurance Specialist

Description

• Execute all activities following quality and regulatory standards and procedures.
• Promote a quality mindset and quality excellence approach to all activities.
• Provide on the floor support to Manufacturing activities.
• Perform review of the manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures.
• Working knowledge and/or ownership of the following quality systems: Change Control, CAPAs, Deviations, and Self inspection auditing, QA reporting and approval of GMP documentation.
• Review and approve Standard Operating Procedures, logbooks and QC data.
• Continue support of continuous improvement culture and industrial excellence methodologies.
• Support employees and respective departments in a manner which is clear in approach, communication, and action.
• Provide proactive communication to customers to ensure timely escalation and resolution of issues.
• Follow up on issues to ensure completion in a timely manner.
• Support cross functional communication in all manners.
• Support batch release of drug substance including compilation of documentation, as necessary.
• Support SAP integration and master data migration, as applicable.
• Support GMP compliance and inspection readiness within organization.
• Assist in coordination of work for the QA Operations team to facilitate timely release of product lots.
  
  

Qualifications

• HS Diploma or equivalent and 8 years of experience in a cGMP environment; OR
• Associate degree and 6 years of experience in a cGMP environment; OR
• Bachelor's degree and 4 years of experience in a cGMP environment.
• Previous experience working with quality systems having oversight of cGMP production operations including some or all of the following: batch release, SAP, batch record review.
• Gown into a manufacturing suite (hair nets, beard covering, gowns), not full face covering.
  
  

Preferred Qualifications

• Bachelor of Science or Bachelor of Arts degree in a scientific discipline.
• Demonstrated experience in regulatory inspection activities.
• Ability to work on multiple projects on a tight timeline.
• Ability to prioritize and the flexibility to adapt to changing priorities.
• Working knowledge of cGMPs and associated regulatory requirements for the manufacture, testing, and release of pharmaceutical/biopharmaceutical products for international markets.
• SAP knowledge.
• Experience working successfully both independently and in a team environment.
• Able to interact with peers, subordinates and senior personnel in multidisciplinary environments including engineering, facility operations, validation, production, and QC.
• Able to prioritize and decide appropriate course of action.
• Root cause analysis experience preferred.
• Vaccines experience a plus.
  
  

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.