Quality Assurance (QA) Specialist I

The Fountain Group; Illinois; On-site; USD 34,000 - 39,000; Full time

Benefits offered by this job

Referral bonus

Job summary

The Fountain Group is seeking a Quality Assurance Specialist I for a prominent client in North Chicago, IL. This on-site role focuses on documenting and investigating product complaints, ensuring compliance with GMP/GLP and cGMP practices.

The position is a 6-month assignment with potential extension or conversion based on performance and budget. A Bachelor’s degree in science or technology is preferred, with background in medical devices.

Qualifications

• Bachelor's degree in science or technology (required).
• Background in medical device is preferred.
• Quality control background within a cGMP environment is highly preferred.
• Experience with sample testing/sample management preferred.

Responsibilities

• Document, investigate, and review non-medical product complaints.
• Test routine to medium complexity products and evaluate results.
• Ensure complaint documentation meets GMP/GLP and Good Documentation Practices.

Skills

GxP knowledge

Quality control

Technical writing

Analytical skills

Education

Bachelor's degree in science or technology

Job description

The Fountain Group is currently seeking a Quality Assurance Specialist I for a prominent client of ours. This position is located in North Chicago, IL. Details for the position are as follows.

• Pay: $25-28/hr.
• 6-month assignment with possibility for extension or conversion based on performance and budget.

Responsibilities

• 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
• Background in medical device is preferred
• Quality control background within a cGMP environment is highly preferred
• Experience with sample testing/sample management preferred

Referral Bonus for any candidate hired.