Quality Systems Specialist: GMP, Pharma & Devices

AbbVie; North Chicago (IL); Sur place; USD 65 000 - 95 000; Plein temps

Avantages offerts par ce poste

Paid time off

Health insurance

401(k) plan

Short-term incentive

Résumé du poste

AbbVie is seeking a Quality Systems Associate Specialist to provide QA support across pharmaceutical, device, and biologics processes. You will contribute to document control, CAPA, change control, and cross-functional audits.

Responsibilities include ensuring compliance with regulatory and corporate standards, supporting training, and driving improvements within the quality system to maintain product integrity.

Qualifications

• Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.
• 3+ years’ experience in quality assurance or relevant experience.
• Knowledge of QA systems and GMP compliance requirements including regulations and standards.
• Experience working in both team setting and independently.
• Strong oral and written communication skills needed.
• Excellent interpersonal skills a plus.

Responsabilités

• Assist with proper integration and support of quality regulations across 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.
• Assist in designing effective quality systems and procedures within cross-functional teams.
• Perform assessments to determine compliance and identify gaps to mitigate improvements.
• Participate in training and education programs for various aspects of QA.

Connaissances

Quality systems

Regulatory knowledge

Documentation control

CAPA

Auditing experience

Formation

Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area

Outils

GMP compliance knowledge

Device/biologics knowledge

Description du poste

AbbVie is seeking a Quality Systems Associate Specialist to provide QA support across pharmaceutical, device, and biologics processes. You will contribute to document control, CAPA, change control, and cross-functional audits.

Responsibilities include ensuring compliance with regulatory and corporate standards, supporting training, and driving improvements within the quality system to maintain product integrity.