Quality Assurance (QA) Specialist

Responsibilities

• Assure complaint records meet global requirements.
• Product complaint documentation, investigation, and review of all non-medical complaint content.
• Responsible for reviewing Medical complaints that involve a non-medical quality related event.
• Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP.
• Responsible that complaint files meet all regulatory requirements.
• Identification of potentially reportable events and notification to appropriate functional groups and management.
• Interface with Third Party Manufacturers, health care professionals, general public, internal customers, functional areas and regulatory agencies.
• Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product, complaint categorization, and CAPA.
• Individual will work in global quality organization processing pharmaceutical, medical device and combination product complaints and inquiries.
• Interface with internal and external customers such as physicians, nurses, pharmacists, hospital personnel, risk managers, purchasing agents, sales representatives, general public, manufacturing sites, technical support, commercial organization and PV regarding product complaints.
• Responsible for product complaint documentation, investigations and identification of potential adverse events and potentially reportable events.
  
  

Qualifications

• A Bachelors Degree required or 1-2 years of relevant work experience.
• Preferred degree in technology or scientific background (MLT, LPN, RN).
• 0-2 years' work experience in a cGMP related industry or in a clinical setting is preferred
• Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.
• Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device
• Reporting regulations (21 CFR 803, 820 and 211) is preferred.
• Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
• Solid written/verbal communication and organizational skills.
• Knowledge and application of computer systems for word processing and complaint management.
• Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
• Complaint handling and investigation skills
• Ability to work with internal teams, external customers, manufacturing sites, and regulatory functions while managing multiple cases and priorities
• Quality/compliance experience in a regulated environment
• Good Documentation Practices, accurate recordkeeping, and clear written communication are key because complaint files must meet global and regulatory standards.
• Analytical skills, technical writing and good documentation.
  
  

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.