Job Description
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
Shift: M-F 8am-5ppm
Pay: $80,000-$100,000, depending on experience
Contract Length: 3-6 months
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: - Develop and update method validation protocols and reports.
- Create Standard Operating Procedures (SOPs) for validated methods.
- Maintain training records for personnel on specific test methods and equipment.
- Conduct installation, operational, and performance qualifications for analytical equipment, specifically FTIR (Fourier Transform Infrared) and GC-FID (Gas Chromatography with Flame Ionization Detector).
- Maintain calibration, preventive maintenance, and change control records.
- Document incidents, deviations, and corrective actions
- Perform and document validation activities for FTIR and GC-FID.
- Develop and validate methods for specific analytical purposes, including FTIR and GC-FID analyses.
- Prepare associated development reports, validation protocols, and validation reports.
Qualifications: - Bachelor's degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field.
- Minimum of 3-5 years of experience in method validation within a GMP-regulated industry (e.g., pharmaceutical, biotechnology, or chemical).
- Hands-on experience in developing and validating analytical methods.
- Experience with analytical instrumentation such as FTIR and GC-FID.
- Strong background in drafting and updating validation documents and SOPs.
Skills: - Strong understanding of GMP, FDA regulations, and method validation principles.
- Excellent written and verbal communication skills.
- Strong attention to detail and organizational skills.
- Proficiency with analytical software and tools.
- 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. 9589550
Job Tags
Holiday work, Full time, Contract work, Shift work,