Quality Assurance Specialist (Batch Record Reviewer)

Location: North Chicago, IL

Contract Length: 6 months (possible extension)

Pay Rate: $20 - $23 (with benefits)

Working Schedule: 8am - 5pm Monday - Friday (Overtime required when needed - including weekends)

Quality Assurance Specialist (Batch Record Reviewer)

The Batch Record Reviewer audits Manufacturing and/or Packaging batch records, performs transactions in inventory systems to release batches for further processing (Packaging) an coordinates problem-solving activities, including solution implementation.

Duties:

• Lead problem-solving activities and coordinate the implementation of identified solutions
• This role will also (depending on facility type); Manufacturing Operations: Complete basic calculations for product yield. Communicate batch release progress or delays to quality and materials management
• Ensure any batch record errors are corrected, all batch record components are present, and exception documents are reference and approved
• Develop and implement process improvements for improved compliance and/or efficiencies
• Interact with other AbbVie departments, external customers, and regulatory agencies. Ensure batch records are retained and filed securely
• Release batch records in electronic systems according to global, local, customer and regulatory requirements
• Interface with various electronic databases/systems to interpret data pertinent for release to specific countries
• Review and audit the data and records generated by Manufacturing and Packaging Operations in processing of a material or product batch
• Ensure Quality goals are met and all practices comply with Company policies and applicable regulations
• Packaging Operations: Ensure all in-process and release testing is complete and all Quality holds are released

Knowledge, Skills, Experience:

• Minimum 2 years experience in Batch Record Release strongly preferred
• 2+ year overall experience in Manufacturing, Quality or Engineering
• Minimum HS Graduate

• Good verbal and written communication skills
• Good interpersonal relations/communication skills
• Knowledge of GMP regulations and standards affecting pharmaceutical products
• Must be available to work daily overtime, including weekends as needed
• Demonstrated analytical skills and attention to detail

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.