Job Summary
We are seeking an experienced Analytical Quality Specialist to support laboratory-based quality control activities. The ideal candidate will have a strong background in analytical method transfers, regulatory compliance, and technical writing.
Key Responsibilities
* Support method validation review and gap assessments
* Author and review analytical method transfer protocols and final reports
* Coordinate and support protocol execution and testing
* Provide direct support to quality analysts during method transfer execution
* Review quality batch data and ensure accuracy and compliance
Quality Systems & Documentation
* Draft, review, and update quality SOPs and analytical test methods
* Complete laboratory investigations (e.g., out-of-specification, out-of-trend), deviations, and corrective actions
* Ensure all quality documentation is in line with data integrity requirements
Operational & Technical Support
* Serve as subject matter expert for laboratory operations supporting new product introductions
* Troubleshoot general laboratory systems and methods
* Support raw material inspection specifications and pharmacopoeial reviews
* Ensure laboratory equipment maintenance and calibration
* Provide laboratory scheduling support and exception-based testing
Training & Collaboration
* Deliver training for quality personnel where applicable
* Collaborate with cross-functional teams including quality assurance, IT, and manufacturing
* Contribute to audit preparation (regulatory agencies, corporate, and clients)
Continuous Improvement & Safety
* Support the implementation of new quality technologies
* Promote and maintain a strong safety culture in the laboratory environment
* Investigate and report non-conformances or incidents in a timely manner
Required Skills and Qualifications
* Bachelor's degree in a life science discipline (e.g., chemistry, biology) required
* Minimum 6 years of practical experience in a GMP quality control environment
* Proven experience in small molecule analytical method transfers, including HPLC/GC
* Strong technical writing skills and experience authoring SOPs, protocols, and reports
* Experience supporting regulatory audits (e.g., FDA, HPRA)
* Familiarity with both drug product and API testing (e.g., dissolution, assay, wet chemistry)
* Experience using Empower software (preferred)