QA Associate

Kelly Outsourcing Consulting Group Kelly OCG, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a QA Associate for an engagement at one of our clients in Gurnee, IL.

This role is a full-time, fully benefited position. As a Kelly OCG employee you will be eligible for Medical, Dental, 401K, and a variety of other benefits to choose from.

You’ll also be eligible for paid time off, including holiday, vacation, and sick / personal time. All Kelly OCG employees receive annual performance review

Objective :

To ensure full GMP compliance by drafting missing documentation, updating existing documentation to address gaps, conducting internal audits, managing supplier programs, handling training, performing mock recalls, and resolving backlog of customer complaints.

Responsibilities :

• Draft and update quality documentation to ensure GMP compliance.
• Maintain and control document approval, distribution, and review processes.
• Conduct comprehensive internal audits to identify non-compliance areas.
• Document findings and outline corrective actions.
• Ensure suppliers complete required questionnaires and comply with standards.
• Draft and update guidelines for supplier evaluation and management.
• Develop training curriculums for SOPs and policies.
• Ensure training is completed, documented, and uploaded to the training management system.
• Perform and document mock recalls to assess readiness and effectiveness.
• Customer Complaints :
• Investigate and document the investigation process to resolve backlog of customer complaints.

Qualifications : Education :

Education :

• Bachelor's degree in Quality Assurance, Life Sciences (i.e. Biology, Chemistry, Biochemistry, etc), Engineering, or a related field.
• Master's degree preferred. Experience :
• Minimum of 3-5 years of experience in Quality Assurance within a GMP-regulated industry (e.g., pharmaceutical, biotechnology, or medical device).
• Proven experience in drafting and updating SOPs and other quality documentation.
• Hands-on experience in conducting internal audits and managing CAPAs.
• Experience with supplier qualification and management.
• Familiarity with training program development and implementation.
• Experience in handling customer complaints and performing mock recalls. Skills :
• Strong understanding of GMP, FDA regulations, and ISO standards.
• Excellent written and verbal communication skills.
• Strong attention to detail and organizational skills.
• Proficiency with electronic quality management systems (eQMS) and training management systems.
• Ability to work independently and collaboratively in a team environment.
• Strong problem-solving and analytical skills.

If you, or someone you know would like to be considered for this opportunity, please apply online today to discuss the next steps.

EX2BIO24

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources.

Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.

As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account.

In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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