Laboratory Technician IV
Job Summary
Perform a range of microbiological testing activities to support product release and site compliance including:
- Environmental Monitoring (EM)
- Water Sampling
- Bioburden Testing
- Endotoxin Testing
- Growth Promotion Testing
- In-Process Testing
- Sterility Testing
- Antimicrobial Preservative Effectiveness Testing (APET)
- Antibiotic Assays
Generate accurate and timely technical reports and test documentation.
Draft review and maintain quality documentation including:
- Standard Operating Procedures (SOPs)
- Protocols
- Training Materials
- Investigation Reports
- Corrective and Preventive Actions (CAPAs)
- Deviations
Trend and analyse microbiological data investigating adverse atypical and out-of-specification (OOS) results as required.
Support validation and qualification activities for microbiology laboratory equipment and test methods.
Ensure all testing activities are performed in compliance with cGMP regulatory requirements and site quality standards.
Qualifications :
Third-level qualification in Microbiology Biological Sciences or a related scientific discipline.
Minimum of 12 months experience within a regulated manufacturing environment preferably in aseptic pharmaceutical production.
Strong working knowledge of the pharmaceutical industry including sterile manufacturing processes and GMP requirements.
Practical experience in aseptic processing contamination control and microbiological laboratory techniques.
Demonstrated understanding of microbiological testing methods environmental monitoring and sterile operations.
Strong technical analytical and problem-solving skills with the ability to investigate and resolve microbiological issues.
Experience working within a highly regulated environment with a commitment to quality compliance and continuous improvement.
Excellent communication documentation and report-writing skills.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more