QA Specialist

Responsibilities

• Investigating return samples for medical device and combination product complaints and inquiries.

• Responsible for product complaint documentation, investigations, identification of product defects and/or damage, and summarizing investigational data into a complaint handling system.

• Interface with internal customers regarding product complaints.

• Responsibilities may include interaction with various third parties.

• Work in a laboratory setting wearing Personal Protective Equipment (e.g., gloves, lab coat, safety glasses).

• Product complaint documentation, investigation, and review of all non-medical complaint content.

• Responsible for reviewing complaints that involve a non-medical quality related problem.

• Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GLP.

• Responsible that complaint data meets all regulatory requirements.

• Comfortable working with sharps (e.g., needles) that are potentially biohazardous.

• Identification of potential reportable events and notification to appropriate functional groups and management.

• Reviews documents and recommends changes to help ensure team objectives are met.

• Budgets their time with minimal supervision to effectively carry out assigned tasks and proposes improvements to processes.

• Takes initiative to be a key player in team activities.

• Completes special projects in resourceful and effective ways to support overall group needs and requirements.

Qualifications

• Bachelor's degree in technology or scientific background preferred or 1-2 years of relevant work experience.

• Solid written/verbal communication and organizational skills.

• Knowledge and application of computer systems for word processing

• Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.

• Able to use time efficiently and effectively to complete workload

• Good Organizational skills

• Effective written and verbal communication skills

• Works and collaborates well on a team

• Lab experience, bio-hazardous lab

• Experience with pharmaceutical or medical devices

• Pharmaceutical experience

• Complaint investigation experience

• Comfortable working with Sharps (needles) may contain biohazardous material

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.