We are seeking a QC Analytical Chemist to analyze raw materials, in-process samples, and finished goods. The ideal candidate will have experience with method development, tech transfer, QC testing, and laboratory deviations/investigations.
Requirements
- Analyzes compounds to determine chemical and physical properties
- Complete routine review of QC test data and related documents
- Monitor and trend QC data results
- Follows established procedures and documents all findings and results timely, concisely, clearly and accurately
- Prepares standards and specifications for processes, facilities, products, and tests
- Measures products for compliance to standards and specifications and reports same
- Provide updates/escalations at daily and weekly site-specific and cross-site meetings
- Experience with method development/qualification, tech transfer, QC testing, and laboratory deviations/investigations
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/ 210/ 211)
- Knowledge of regulatory guidance and experience maintaining QC lab GMP compliance and audits
- Assessment of GMP systems currently in place to ensure compliance
- Proficiency in MS Word, Excel, Power Point and other applications
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
Benefits
- Competitive compensation package
- Health, dental, and vision benefits
- 401K program