Quality Assurance Specialist

Job Description

• The Quality Assurance (QA) Specialist I is responsible for product complaint documentation, investigations, identification of product defects and/or damage, and summarizing investigational data into a complaint handling system.
• Individual uses expertise and a thorough thought process to determine next step in testing.
• They will perform the complaint return sample testing and investigation (across multiple products).
• The individual will analyze and test routine to medium complexity products, and evaluate results.
• Individual has responsibility for completing assigned work tasks and goals and can independently prioritize work schedule in order to meet both objectives.
• Review & approve other simple to medium complexity investigation results, under the guidance of senior lab analysts.
• Perform product complaint documentation, investigation, and review of all non-medical complaint content.
• Analyze and test routine to medium complexity products, and evaluate results.
• Performs test methods as written to support product complaint investigation activities.
• Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GLP.
• This requires good analytical skills, technical writing, and good documentation.
• Responsible for complaint data meeting all regulatory requirements.
• Identification and initiation of appropriate exception documents in accordance with procedural requirements; supports the investigation process
• Supports redline changes to local documents; Supports team to meet broader business objectives; Assists in projects and activities
• Budgets their time with minimal supervision to effectively carry out assigned tasks and proposes improvements to processes across the QA lab.
• Takes initiative to be a key player in team activities.
• Understands, implements, and maintains a safe work environment and good manufacturing practices with respect to procedural requirements and laboratory records and requirements.
• Maintains lab for safety and compliance.
• Maintains training certificates as needed for assigned job tasks.
• Interprets data results for conformance with expected results as defined per procedures
• Understands laboratory techniques and principles performed and can independently troubleshoot and resolve analytical techniques and instrument issues.
• Understands, implements and maintains GxP with respect to laboratory records, procedures and systems in accordance with procedural requirements
  
  

Qualifications

• Bachelor's degree in science or technology
• Lab Experience; Device background preferred
• Agile; Can effectively manage time and handle multiple tasks
• Solid written/ verbal communication skills and interpersonal skills
• Critical thinking skills
  
  

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.