QA Associate II

Kelly Services; Olde West Chester (OH); On-site; USD 41,000 - 44,000; Full time

Job summary

Kelly Services is seeking a QA Associate II for a 2-year contract at a West Chester, OH site. The role supports QA activities across the Process Execution Team (PET) and related areas, including aseptic monitoring, on-the-floor review, batch record review, documentation support, forward processing, and walkthroughs to ensure quality and compliance.

Year 1 focuses on training in the department with classroom documentation and eLMS/eDMS tasks, followed by Year 2 QA responsibilities.

Qualifications

• High school diploma or equivalent.
• Considerable experience in Quality Assurance within a GMP setting.
• Ability to become aseptic gowning certified and maintain certification.
• Excellent oral and written communication skills.
• Strong ability and motivation to learn.

Responsibilities

• Maintain a high level of understanding of relevant production processes and quality systems.
• Perform QA review of GMP documentation that has direct impact on the activities performed by and facilities utilized in their areas as applicable.
• Collaborate with and influence other Quality professionals across the organization to ensure consistent application of key quality systems.
• Execute QA processes including batch record review, forward processing, and quality issue resolution to maintain the flow of products and documents to meet site objectives.
• Collaborate with and influence other PET/assigned area members to facilitate process improvements and risk assessments; benchmark QA practices to identify innovative efficient and effective practices.
• Stay abreast of evolving regulatory compliance practices and recommend implementation strategies to area leaders.

Skills

High school diploma

Quality Assurance experience

Aseptic gowning certification

Oral and written communication

Learning mindset

Education

Bachelor’s degree; master’s degree in quality assurance/regulatory affairs desirable

Job description

QA Associate II

Kelly® Science & Clinical is seeking a QA Associate II for a 2-year contract position with a national pharmaceutical leader at their site in West Chester, OH. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Compensation:$30-32/hr
Schedule:

• Assignment 1 (August 2026-August 2027): Mon-Fri, 8AM-5:30PM
• Assignment 2 (August 2027-August 2028): 2/2/3, night shift

Location: West Chester, OH

SUMMARY

This position is responsible for all QA activities that directly support execution of the process both within the Process Execution Team (PET) and in assigned areas outside of the PETs. These activities may include but are not limited to aseptic monitoring, on the floor review, batch record review, documentation support, forward processing, and walkthroughs.

RESPONSIBILITIES

Year 1: Training Department

• Processing classroom training documentation and granting credit within the eLMS. (learning management system)
• Reviewing/Verifying documents for training requirements in the eDMS (document management system) and creating training requirements as needed.
• Processing training assignments

Year 2: QA

At this level the incumbent is not necessarily performing all the essential job functions of the role immediately. The incumbent may begin by specializing in one or more of these responsibilities whilst working to develop a solid knowledge of the process being supported and applicable cGMPs. Over time the incumbent will be expected to obtain the necessary training to become skilled in all major responsibilities of the role.

• Maintain a high level of understanding of relevant production processes and quality systems
• Perform QA review of GMP documentation that has direct impact on the activities performed by and facilities utilized in their corresponding areas as applicable.
• Collaborate with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems
• Execute QA processes including batch record review, forward processing, and quality issue resolution to maintain the flow of products and documents to meet site objectives
• Collaborate with and influence other PET/assigned area members to facilitate process improvements and risk assessments; benchmark QA practices to identify innovative efficient and effective practices
• Stay abreast of evolving regulatory compliance practices and recommend implementation strategies to area leaders

QUALIFICATIONS

Minimum Requirements

• High school diploma
• Considerable experience in Quality Assurance within a GMP setting
• Ability to become aseptic gowning certified and maintain certification
• Excellent oral and written communication skills
• Strong ability and motivation to learn

Preferred Background

• Bachelor’s degree; master’s degree in quality assurance/regulatory affairs is desirable
• Previous experience in a Lean, process-centric organization with emphasis on continuous improvement
• Multi-site / multi-functional experience