Katalyst CRO
Join to apply for the
Quality Systems Specialist
role at
Katalyst CRO Join to apply for the
Quality Systems Specialist
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Serve as global process support for Deviation, CAPA, Change Control, Reg Client, and Training processes. Facilitate analysis of Quality Systems metrics and performance periodically. Manage Quality Systems deviations and CAPAs, ensuring proper investigation, resolution, and preventive measures. Oversee Regulatory Intelligence assessments and maintain associated documentation. Facilitate the Change Control Review Board and maintain associated documentation. Partner with subject matter experts and business representatives to identify GxP training content needs and GXP curricula modification. Support development of Quality related training content. Support quality systems audits and regulatory inspections. Provide guidance and support to site quality teams in process implementation.
Responsibilities
Serve as global process support for Deviation, CAPA, Change Control, Reg Client, and Training processes. Facilitate analysis of Quality Systems metrics and performance periodically. Manage Quality Systems deviations and CAPAs, ensuring proper investigation, resolution, and preventive measures. Oversee Regulatory Intelligence assessments and maintain associated documentation. Facilitate the Change Control Review Board and maintain associated documentation. Partner with subject matter experts and business representatives to identify GxP training content needs and GXP curricula modification. Support development of Quality related training content. Support quality systems audits and regulatory inspections. Provide guidance and support to site quality teams in process implementation.
Requirements:
Bachelor's degree in Life Sciences, Engineering, or related field. 2+ years of experience in Quality Systems within biotechnology or pharmaceutical industries. 1+ years of experience in manufacturing, operations, or related business areas. Demonstrated experience in process ownership and quality systems management. Strong understanding of GMP, GLP, GCP regulations and ICH guidelines. Experience with electronic quality management systems (Veeva). Experience with Lean Six Sigma methodologies. International work experience. Experience with change management and organizational development.
Skills:
Strong process thinking and analytical skills. Strong experience in Excel. Excellence in project management and organization. Outstanding communication and presentation abilities. Proven ability to influence without direct authority. Strong facilitation and training skills. Seniority level
Seniority level
Associate Employment type
Employment type
Contract Job function
Job function
Quality Assurance Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Quality System Specialist jobs in
Chicago, IL . Des Plaines, IL $66,700 - $133,300 2 days ago Quality Assurance Specialist (Chemistry)
Sr. Quality Assurance Tech & Labeling Compliance Coordinator
Chicago, IL $65,000.00 - $75,000.00 6 days ago Niles, IL $72,300.00 - $108,500.00 1 week ago Deerfield, IL $79,300.00 - $127,000.00 12 hours ago Greater Chicago Area $45.00 - $65.00 1 week ago Elk Grove Village, IL $70,000.00 - $90,000.00 2 weeks ago Associate Quality Engineer - Operating Room
Chicago, IL $68,640.00 - $99,320.00 1 week ago Chicago, IL $56,700.80 - $60,008.00 1 week ago Elk Grove Village, IL $75,000.00 - $85,000.00 1 week ago Rosemont, IL $133,000.00 - $166,000.00 11 hours ago Supplier Quality Engineer- Manufacturing
Chicago, IL $90,000.00 - $150,000.00 1 week ago Niles, IL $163,000.00 - $245,000.00 6 days ago Quality Engineer IATF 16949 Lead Auditor
Bloomingdale, IL $80,000.00 - $90,000.00 13 hours ago Chicago, IL $72,009.60 - $74,505.60 1 day ago Northfield, IL $79,560 - $115,440 1 week ago Northbrook, IL $92,000 - $115,000 2 weeks ago Northbrook, IL $92,000 - $115,000 2 weeks ago Senior Quality Engineer (Pharmacy Technology)
Deerfield, IL $88,700 - $141,800 12 hours ago Chicago, IL $100,800 - $169,900 5 days ago Northlake, IL $85,000 - $90,000 2 weeks ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Quality Systems Specialist
role at
Katalyst CRO Join to apply for the
Quality Systems Specialist
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Serve as global process support for Deviation, CAPA, Change Control, Reg Client, and Training processes. Facilitate analysis of Quality Systems metrics and performance periodically. Manage Quality Systems deviations and CAPAs, ensuring proper investigation, resolution, and preventive measures. Oversee Regulatory Intelligence assessments and maintain associated documentation. Facilitate the Change Control Review Board and maintain associated documentation. Partner with subject matter experts and business representatives to identify GxP training content needs and GXP curricula modification. Support development of Quality related training content. Support quality systems audits and regulatory inspections. Provide guidance and support to site quality teams in process implementation.
Responsibilities
Serve as global process support for Deviation, CAPA, Change Control, Reg Client, and Training processes. Facilitate analysis of Quality Systems metrics and performance periodically. Manage Quality Systems deviations and CAPAs, ensuring proper investigation, resolution, and preventive measures. Oversee Regulatory Intelligence assessments and maintain associated documentation. Facilitate the Change Control Review Board and maintain associated documentation. Partner with subject matter experts and business representatives to identify GxP training content needs and GXP curricula modification. Support development of Quality related training content. Support quality systems audits and regulatory inspections. Provide guidance and support to site quality teams in process implementation.
Requirements:
Bachelor's degree in Life Sciences, Engineering, or related field. 2+ years of experience in Quality Systems within biotechnology or pharmaceutical industries. 1+ years of experience in manufacturing, operations, or related business areas. Demonstrated experience in process ownership and quality systems management. Strong understanding of GMP, GLP, GCP regulations and ICH guidelines. Experience with electronic quality management systems (Veeva). Experience with Lean Six Sigma methodologies. International work experience. Experience with change management and organizational development.
Skills:
Strong process thinking and analytical skills. Strong experience in Excel. Excellence in project management and organization. Outstanding communication and presentation abilities. Proven ability to influence without direct authority. Strong facilitation and training skills. Seniority level
Seniority level
Associate Employment type
Employment type
Contract Job function
Job function
Quality Assurance Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Quality System Specialist jobs in
Chicago, IL . Des Plaines, IL $66,700 - $133,300 2 days ago Quality Assurance Specialist (Chemistry)
Sr. Quality Assurance Tech & Labeling Compliance Coordinator
Chicago, IL $65,000.00 - $75,000.00 6 days ago Niles, IL $72,300.00 - $108,500.00 1 week ago Deerfield, IL $79,300.00 - $127,000.00 12 hours ago Greater Chicago Area $45.00 - $65.00 1 week ago Elk Grove Village, IL $70,000.00 - $90,000.00 2 weeks ago Associate Quality Engineer - Operating Room
Chicago, IL $68,640.00 - $99,320.00 1 week ago Chicago, IL $56,700.80 - $60,008.00 1 week ago Elk Grove Village, IL $75,000.00 - $85,000.00 1 week ago Rosemont, IL $133,000.00 - $166,000.00 11 hours ago Supplier Quality Engineer- Manufacturing
Chicago, IL $90,000.00 - $150,000.00 1 week ago Niles, IL $163,000.00 - $245,000.00 6 days ago Quality Engineer IATF 16949 Lead Auditor
Bloomingdale, IL $80,000.00 - $90,000.00 13 hours ago Chicago, IL $72,009.60 - $74,505.60 1 day ago Northfield, IL $79,560 - $115,440 1 week ago Northbrook, IL $92,000 - $115,000 2 weeks ago Northbrook, IL $92,000 - $115,000 2 weeks ago Senior Quality Engineer (Pharmacy Technology)
Deerfield, IL $88,700 - $141,800 12 hours ago Chicago, IL $100,800 - $169,900 5 days ago Northlake, IL $85,000 - $90,000 2 weeks ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr