Senior Analyst, Quality Engineering (On-site)

BioSpace; North Chicago (IL); On-site; USD 82,000 - 158,000; Full time

Job summary

A leading company in healthcare is seeking a Senior Analyst in Quality Engineering for their North Chicago location. The role involves ensuring compliance with quality standards, reviewing documentation, and leading audits. Ideal candidates will hold a Bachelor's degree and possess substantial experience in Quality Assurance, alongside strong leadership and communication skills.

Benefits

Health insurance

Paid time off

401(k)

Participation in incentive programs

Qualifications

• Bachelor's degree in life sciences, engineering, or related field required.
• At least 4 years of experience in Quality Assurance or similar roles.
• Knowledge of US and international quality regulations is crucial.

Responsibilities

• Review and approve batch records and associated documentation.
• Draft and approve exception reports, CAPAs, and related documents.
• Generate and report quality metrics to management.

Skills

Organizational skills

Leadership skills

Communication

Problem-solving

Education

Bachelor's degree in life sciences, engineering, or related field

Job description

Senior Analyst, Quality Engineering (On-site)

Join us as a Senior Analyst, Quality Engineering (On-site) at BioSpace.

Company Overview

AbbVie's mission is to discover and deliver innovative medicines and solutions that address serious health issues today and tomorrow. We aim to make a significant impact across key therapeutic areas including immunology, oncology, neuroscience, and eye care, along with our products in the Allergan Aesthetics portfolio. For more information, visit www.abbvie.com. Follow us on social media @abbvie.

Job Purpose

Responsible for quality-related tasks such as reviewing batch records, approving quality documentation, managing exception reports, and ensuring compliance with quality standards.

Key Responsibilities

• Review and approve batch records and associated documentation
• Provide quality approval for materials in management systems
• Draft and approve exception reports, CAPAs, and related documents
• Review clinical documentation and specifications as applicable
• Develop and review policies, procedures, and related documents
• Lead or support audits by regulatory agencies and customers
• Participate in product development teams to address quality issues
• Generate and report quality metrics to management
• Support QA activities and process improvements

Qualifications

• Bachelor's degree in life sciences, engineering, or related field
• At least 4 years of experience in Quality Assurance or similar roles, preferably in healthcare
• Knowledge of US and international quality regulations
• Strong organizational and leadership skills
• Excellent communication and problem-solving abilities
• Professional certifications like ASQ CQA or CQE are desirable

Additional Information

The position is onsite at our North Chicago location, 5 days a week. Compensation ranges from $82,500 to $157,500, with benefits including health insurance, paid time off, 401(k), and participation in incentive programs. The actual salary will depend on experience and location.

AbbVie is an equal opportunity employer. For accommodations or more info, visit our website links provided.

Employment Details

• Employment Type: Full-time
• Job Function: Quality Assurance