QA Specialist

Job Description

• Individual will work in client global quality organization processing pharmaceutical, medical device and combination product complaints and inquiries.
• Interface with internal client 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 client product complaints.
• Responsible for product complaint documentation, investigations and identification of potential adverse events and potentially reportable events.
• Responsibilities may include creation and submission of regulatory reports, creation of customer communications and interface with various third parties.
• 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 problem.
• Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product.
• 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, client functional areas and regulatory agencies.
  
  

Qualifications

• Bachelor Degree required.
• Preferred degree in technology or scientific background (MLT, LPN, RN).
• Relevant educational experience or work experience in pharmaceutical field or product complaint field.
• Critical thinking, critical reading, and clear communication skills.
• Experience with the Microsoft suite of business programs (Outlook, Excel, Teams, PowerPoint, Word, etc).
• Ability to focus and prioritize work tasks.
• 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.
• 0-3 years' work experience in a cGMP related industry or in a clinical setting is preferred
• Good analytical skills, technical writing and good documentation.
• Work Schedule M-F 8-4:30/5
  
  

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.