Quality Specialist
Location: Chicago, IL
Pay: $25-31/HR, based on experience
Shift: M-F, 8:30AM to 5:30PM
Qualifications:
- A minimum of a BA or BS in Biological Sciences or a related technical field is required.
- Prior experience in the pharmaceutical industry is a must
- Familiarity with regulatory compliance standards
Responsibilities:
- Support the manufacturing team with various documentation tasks.
- Review executed batch records across multiple departments (Drug Product, Secondary Packaging, Upstream, and Downstream).
- Manage filing of change controls, deviations, and CAPAs within the manufacturing department.
- Track and ensure the timely closure of QMS documents.
- Utilize investigation tools such as the 5Why or 6M method for critical/major investigations.
- Collaborate with cross-functional teams to ensure timely closure of investigations and QMS action items.
- Author batch records, SOPs, and related forms required for manufacturing processes.
- Submit all GMP documents to QA for review and approval.
- Participate in regulatory inspections and compliance activities.
- Support manufacturing processes during critical campaigns, including rotating shifts (no more than 10% of time spent on shopfloor tasks).
- Perform other duties as assigned.
- Adhere to all company policies and standards.