QA Associate: GMP Compliance & Manufacturing Oversight

Catalent Pharma Solutions; Kansas City (MO); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Health benefits on day one

PTO + 8 holidays

Tuition reimbursement

Career growth opportunities

Diversity & inclusion

Job summary

Catalent Kansas City is seeking an Associate, Quality Assurance to join our team. This role involves performing varied work that requires some evaluation and originality while following established protocols and work plans, supporting quality oversight of manufacturing processes, and ensuring compliance with cGMPs, FDA, and MHRA guidelines.

Shift: M-F 6am-2:30pmLocation: Kansas City, MO100% Onsite. The successful candidate will review batch records, identify deviations, approve batch

Qualifications

• Bachelor's degree in a scientific discipline or at least one year GMP experience.
• Follow instructions and apply all elements of the quality system.
• Able to identify issues and communicate with management.
• Strong written and verbal communication with stakeholders.

Responsibilities

• Oversee quality support functions for manufacturing.
• Review batch records, cleaning records, and logbooks.
• Ensure compliance with cGMP, FDA, MHRA and SOPs.
• Identify deviations and direct corrective actions.
• Review and approve batch documentation for SOPs and cGMPs.
• Participate in QA programs, controls and audits.
• Complete monthly and daily facility audits.
• Assist with floor activities and equipment/room approvals.

Skills

Quality oversight

cGMP knowledge

Documentation skills

Data analysis

Communication

Education

Bachelor's degree in a scientific discipline

Tools

MS Office

LIMS

Job description

Catalent Kansas City is seeking an Associate, Quality Assurance to join our team. This role involves performing varied work that requires some evaluation and originality while following established protocols and work plans, supporting quality oversight of manufacturing processes, and ensuring compliance with cGMPs, FDA, and MHRA guidelines.

Shift: M-F 6am-2:30pmLocation: Kansas City, MO100% Onsite. The successful candidate will review batch records, identify deviations, approve batch