JOB Senior Scientist, Quality and Compliance
LOCATION North Scottsdale
PAY $90K to $115K
DURATION Direct Hire
Responsible for providing quality control, quality assurance, compliance, and technical support of product development and manufacturing operations. This position will participate in the establishment and maintenance of Quality systems.
- Provide direction to contract laboratories for method development and validation activities. Methods will include both routine and novel approaches to analytical procedures. Includes direct communication with all levels of laboratory personnel, all available resources, and troubleshooting analytical methodology issues long-distance or by traveling to the laboratory.
- Write, or review and approve, method validation protocols and summary reports to facilitate the implementation of methods in support of business and/or logistical needs. Assessment of the data generated, determining if trends or analytical issues exist. Requires familiarity with method development and validation and the chemistry involved with the procedure.
- Assess current product test methods and specifications to assure compliance with applicable industry and regulatory standards. Requires full understanding of all methodologies and applicable regulations as well as ability to communicate findings effectively in order to prioritize projects. Requires knowledge of ICH stability study design and expiry estimations.
- Develop, or review and approve, controlled documents to include standard operating procedures, specifications, stability protocols, validation protocols, etc. Assures compliance with cGMPs. Will act as liaison with Product Development management to establish and approve product test specifications.
Effective and efficient evaluation of acceptability of contract laboratory’s method development and validation activities and documentation. Must be able to review Out of Specification reports and product investigations from a scientific and regulatory perspective. Auditing of contract laboratories. Bench Chemistry experience to include operation of HPLC and GC, interpretation of data, and familiarization with chromatographic operating systems.
EXPERIENCE | BACKGROUND:
Requires at least a Bachelors Degree in Chemistry or other life science plus 10 years of relevant experience. Experience includes Chemistry laboratory testing in a cGMP controlled environment including automated chromatographic analyses and wet chemistry, evaluation of out of specification reports and product investigations, deviation assessments, and auditing of contractors/suppliers. Must include method development and validation experience. Must include HPLC and GC experience.
Monster - 6 months ago