The Individual will support cGMP QC activities for raw materials, drug substances, and finished products at the company’s manufacturing facility. This role includes performing data review of Quality Control test records, EM results, Logbooks, and Lab Notebooks. Here’s What You’ll Need (Basic Qualifications) Education: Degree Experience: STEM degree; experience in a cGMP laboratory setting, with hands-on experience in microbiology techniques is preferred, but not required.
Here’s What You’ll Bring to the Table (Preferred Qualifications)
- Experience with microbiology test methods (growth promotion, bioburden, culture purity, endotoxin).
- Experience with environmental monitoring
- Experience in technical writing
- Familiarity with electronic databases (e.g. LIMS, MODA, SAP).
- Understanding of relevant and current FDA, EU, ICH guidelines and regulations.
- Experience with laboratory equipment calibration and maintenance.
Here’s What You’ll Need (Basic Qualifications) Experience: STEM degree; experience in a cGMP laboratory setting, with hands-on experience in microbiology techniques is preferred, but not required. This position is site-based, requiring you to be at the company’s site full-time. This position is not eligible for remote work. Here’s What You’ll Bring to the Table (Preferred Qualifications)
- Experience with microbiology test methods (growth promotion, bioburden, culture purity, endotoxin).
- Experience with environmental monitoring
- Experience in technical writing
- Familiarity with electronic databases (e.g. LIMS, MODA, SAP).
- Understanding of relevant and current FDA, EU, ICH guidelines and regulations.
- Experience with laboratory equipment calibration and maintenance.
Salary: $36 – $36.15 per hour
Shift: Second
Work Hours: 2 PM – 10 PM
Education: Associate
Responsibilities
Here’s What You’ll Do
- Review executed QC test records for product release (including Environmental Monitoring Data).
- Review Logbooks and Laboratory Notebooks.
- Supports authoring and revision of laboratory procedures, test record forms and reports.
- Participate in quality systems records such as deviations, change controls, CAPAs, and non-conformance investigations.
- Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
- Ensure compliance with cGMP documentation and regulatory guidelines.
- Establish and maintain a safe laboratory working environment.
- Provide support during internal and vendor audits and collaborate on continuous improvement initiatives.
Skills
- Quality Control
- Quality Assurance
- Inspection
Qualifications
- Years of experience: 2 years
- Experience level: Experienced
