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Quality Assurance Associate II
West Chester, OH, US
Scientific
High School or equivalent
Full Time, Temp to Hire
30-32
Experienced (Non-Manager)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
West Chester, OH, US
30-32
Experienced (Non-Manager)
Full Time, Temp to Hire
Biotechnology/Pharmaceuticals
On-site
Scientific
High School or equivalent
First Shift (Day)
Job details
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 (June 2026-June 2027): Mon-Fri, 8AM-5:30PM
- Assignment 2 (June 2027-June 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
- 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
- Considerable experience in Quality Assurance
P#1
Send Resumes to Jacqueline.Sayoc@KellyScientific.com
10227785
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