Quality Systems Associate: QA & Compliance Specialist

Regulatory Toolkit; Chicago (IL); Sur place; USD 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Paid time off

Medical/dental/vision insurance

401(k)

Résumé du poste

AbbVie seeks a Quality Systems Associate Specialist to provide QA support across drug, biologics, device and combination products. You will help manage documentation, audits, CAPA, training and regulatory compliance from raw material inspection through final shipment.

Ideal candidates have a Bachelor's in a technical field and 3+ years in QA, with strong written and verbal communication and the ability to work both independently and in cross-functional teams.

Qualifications

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred.
• 3+ years’ experience in quality assurance, quality oversight or relevant experience.
• Technical knowledge in QA, Regulatory, Process Sciences, Manufacturing Operations is preferred.
• Knowledge of QA systems and GMP compliance requirements for device, biologics, and pharmaceutical products.

Responsabilités

• Assist with proper integration and support of quality regulations for drug, biologics, device, and/or combination products.
• Assist project teams in planning, preparation, review and approval of quality documentation.
• Complete and route change requests for process document creation, maintenance, and implementation.
• Create quality system documentation and specifications with guidance from technical teams.
• Assist with or co-lead audits of documentation, facilities and equipment.
• Contribute to design of effective quality systems, procedures and processes within cross-functional teams.
• Perform assessments to determine compliance and identify gaps for improvements.
• Participate in training and education programs for quality assurance.

Connaissances

Quality, Regulatory, Process Sciences,

Strong communication skills

Project coordination

Team collaboration

Formation

Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering

Description du poste

AbbVie seeks a Quality Systems Associate Specialist to provide QA support across drug, biologics, device and combination products. You will help manage documentation, audits, CAPA, training and regulatory compliance from raw material inspection through final shipment.

Ideal candidates have a Bachelor's in a technical field and 3+ years in QA, with strong written and verbal communication and the ability to work both independently and in cross-functional teams.