QA Leader - GMP Compliance & Process Improvement

Quality Search Personal GmbH; Irvine (CA); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401K matching

Job summary

JobRx, Inc. in Irvine, CA is looking for a Quality Assurance professional with over 6 years of experience in a GMP facility. The successful candidate will assist in supervising quality programs, manage compliance profiles, and lead investigation activities while adhering to cGMP regulations.

The role requires strong leadership skills, a scientific degree, and proficiency in interpreting technical procedures. Benefits include medical, dental, vision, and a company matching 401K.

Qualifications

• 6+ years of experience in Quality Assurance in a GMP facility.
• Ability to interpret SOP's and GMP regulations: 21 CFR 111, 11, 210, 211.
• Strong knowledge of validation and auditing principles.

Responsibilities

• Assist in supervision of various quality programs.
• Manage compliance profile and drive continuous improvements.
• Review and approve protocols and reports for qualifications.
• Lead investigation activities and root-cause analyses.
• Comply with cGMP regulations and standard operating procedures.

Skills

Quality Assurance expertise

Leadership and management skills

Strong communication skills

Statistical process control

Education

Bachelor's Degree in a scientific discipline

Tools

ASQC quality certifications

ISO 9000 training

Job description

JobRx, Inc. in Irvine, CA is looking for a Quality Assurance professional with over 6 years of experience in a GMP facility. The successful candidate will assist in supervising quality programs, manage compliance profiles, and lead investigation activities while adhering to cGMP regulations.

The role requires strong leadership skills, a scientific degree, and proficiency in interpreting technical procedures. Benefits include medical, dental, vision, and a company matching 401K.