QA Specialist I - cGMP Compliance & SOP Champion

Avecia Pharma; Cincinnati (OH); Vor Ort; USD 58.100 - 71.100; Vollzeit

Zusammenfassung

A chez Avecia Pharma, the Quality Assurance Specialist will document and audit cGMP practices across the site, developing and revising QA procedures to strengthen cGMP compliance per USFDA Title 21 CFR Part 210, 211 and ICH Q7 guidance.

Key responsibilities include coordinating with departments to meet GMP requirements, approving SOPs, and ensuring batch records and QC docs meet quality standards. The role emphasizes liaison with clients and cross-functional collaboration.

Qualifikationen

• BS/BA in science with 1–3 years QA cGMP experience or an Associate degree with 5+ years QA cGMP experience in API manufacturing or related industry.
• High level of knowledge in cGMP guidelines as per ICH Q7A.
• Experience writing and reviewing GMP documents.
• Strong problem solving for non-routine analytical issues.
• Excellent written and verbal communication skills.

Aufgaben

• Act as departmental resource for cGMP manufacturing programs.
• Collaborate with all departments to ensure programs are delivered on time.
• Make and act upon GMP decisions.
• Write, review, and approve SOPs and other compliance documents for cGMP programs.
• Review and authorize batch production records and QC documents.
• Set up and track material flow and labeling to ensure cGMP compliance.
• Liaise between Avecia and clients regarding cGMP compliance.
• Support highest quality customer service through internal collaboration.

Kenntnisse

cGMP QA knowledge

GMP documentation

Analytical problem solving

Communication skills

Ausbildung

BS/BA in science

Associate degree in related field

Jobbeschreibung

A chez Avecia Pharma, the Quality Assurance Specialist will document and audit cGMP practices across the site, developing and revising QA procedures to strengthen cGMP compliance per USFDA Title 21 CFR Part 210, 211 and ICH Q7 guidance.

Key responsibilities include coordinating with departments to meet GMP requirements, approving SOPs, and ensuring batch records and QC docs meet quality standards. The role emphasizes liaison with clients and cross-functional collaboration.