Pharmaceutical Quality Assurance Lead — 3rd Shift (GMP)

The International Society for Pharmaceutical Engineering, Inc.; Rock Hill (SC); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Paid PTO

Job summary

The International Society for Pharmaceutical Engineering, Inc. is seeking a Quality Assurance professional for a 3rd shift in a FDA-regulated manufacturing environment in Rock Hill, SC.

The role involves training staff, ensuring GMP compliance, and reviewing batch records and SOPs to maintain quality throughout production. Responsibilities include supervising quality control personnel, performing inspections, maintaining calibration of equipment, and supporting audits.

Qualifications

• Bachelor's degree in Science is required.
• 3+ years of experience in a cGMP environment are required.

Responsibilities

• Train, supervise, and evaluate quality control team members.
• Ensure proper GMP compliance and SOP procedures are followed.
• Review of SOPs.
• Document Control and Batch Record Review.
• Provide, and oversee, inspection activity for product throughout production cycle.
• Monitor all operations that affect quality.
• Supervise and guide inspectors, technicians and other staff.
• Apply total quality management tools and approaches to analytical and reporting processes.
• Work to resolve noncompliance issues with materials or final products.
• Ensuring and maintaining the calibration of all equipment and instruments.
• Preparing and periodically reviewing all QC SOPs.
• Supports and participate to all the internal/external audits.
• Conducting investigations.
• Schedule and coordinate preparations for product inspections and testing

Education

Bachelor's degree in Science

Job description

The International Society for Pharmaceutical Engineering, Inc. is seeking a Quality Assurance professional for a 3rd shift in a FDA-regulated manufacturing environment in Rock Hill, SC.

The role involves training staff, ensuring GMP compliance, and reviewing batch records and SOPs to maintain quality throughout production. Responsibilities include supervising quality control personnel, performing inspections, maintaining calibration of equipment, and supporting audits.