Lachman Consultants, the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries, is seeking per diem Analytical Chemists.
Chemists must have demonstrated regulatory compliance expertise as it relates to the testing of drug products and/or active pharmaceutical ingredients. Experience should include:
- OOS Investigations
- Laboratory investigations including OOS and mitigation, deviations
- Chromatography data reviews
- Laboratory method reviews
- Data Integrity
- GMP / GLP audits covering laboratory procedures and practices for Quality Control Laboratories
- Documentation practices
- Analytical methods development
- Validation and transfer
- Instrument qualification
- Training programs
- Stability studies
- CAPAs / remediation
- Project management
- Electronic data reviews
- Remediation of laboratory control systems
- Change control
- Quality Assurance or Regulatory Agency experience a plus.
- B.S. / M.S. / Ph.D. in Chemistry
- Minimum of 10 years’ laboratory experience in a Quality Control setting with demonstrated laboratory supervisory / managerial experience.
- Detailed knowledge of current FDA, ICH, and USP regulations / guidances and expectations
- Strong communication / presentation skills, verbal and written, are required for interaction with clients and coworkers
- Ability to recognize and differentiate importance of issues and prioritize accordingly
All candidates must have verifiable and recent “hands on” experience, including demonstrated remediation skills in the pharmaceutical industry. Only competent, well qualified, and highly motivated chemists with a proven track record of success need submit resume for consideration to be engaged as an independent consultant. Must be willing to travel both domestically and internationally.