Product Development QA Manager

AbbVie; North Chicago (IL); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

401(k)

Paid time off

Job summary

Responsibilities include reviewing records, leading audits, updating procedures, and driving process improvements within PDQA. Suitable for strong problem solvers with GMP and regulatory experience.

Qualifications

• Bachelor's degree in life sciences (biology, chemistry, or engineering) or equivalent.
• Master’s degree is preferred but not required based on commensurate experience.
• 6+ years industry experience in Quality Assurance or related field.
• Supervisory or project management experience is a plus.

Responsibilities

• Review and approve batch records and release batches or analytical records.
• Write/review/approve processes and procedures and related documents.
• Lead/assist in audits conducted by regulatory agencies, customers, and R&D GxP Compliance.
• Maintain awareness of regulatory changes impacting R&D and incorporate procedural updates.
• Provide area-specific management support as a backup to the manager.
• Support daily product release activities as applicable to the organization.
• Drive consistency and continual process improvements within PDQA.
• Write/review/approve exception reports, including high impact ERs.
• Lead/participate in assigned project teams for product development.
• Monitor process effectiveness and quality of project work with management.

Skills

Quality Assurance

Regulatory Compliance

Audit Preparation

Problem Solving

Education

Bachelor's degree in life sciences

Master's degree (preferred)

Job description

Responsibilities include reviewing records, leading audits, updating procedures, and driving process improvements within PDQA. Suitable for strong problem solvers with GMP and regulatory experience.