Quality Specialist I
Catalent•Kansas City, MO
•Onsite
About The Position
The Quality Assurance Specialist I supports clinical trial projects, ensuring all work is performed in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). They are responsible for implementing and maintaining quality assurance processes throughout the product lifecycle. This involves ensuring that all documentation is accurate, up-to-date, and properly maintained in accordance with regulatory requirements.
Requirements
- Bachelor’s degree in a scientific discipline or equivalent knowledge and experience.
- High school degree with 2+ years of Quality Assurance experience in a GMP manufacturing environment.
- Receives instruction, guidance and direction from others
- Uses existing procedures to solve routine problems
- Ability to identify aberrant data and potential quality/compliance concerns escalating to management
- Ability to work effectively under pressure to meet deadlines
- Has sufficient skills and knowledge in the use of computers and associated computer technology.
Responsibilities
- Participate in continuous improvement initiatives to enhance process, systems, and procedures related to quality management
- Review QC data for completeness and acceptability
- Approve Release packets with supervision
- Lead Investigator for Deviations and Complaints
- Hosting CAPA review and deviation management meetings
- Reviewing /approve change controls and change actions with supervision
Benefits
- Competitive medical benefits
- 401K
- 152 hours PTO
- 8 Paid Holidays
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
