Career Opportunities
Quality Assurance Officer-Bioanalytical Chemistry
Qualifications
- Bachelor's Degree.
- Excellent editing skills.
- Good computer skills.
- Solid writing and proofreading skills.
- Ability to prioritize and meet deadlines with a high volume of reports.
- Ability to work on several projects concurrently in fast-paced environment.
- Independent worker with teamwork orientation.
- Strong organizational skills required.
- Must have experience in performing or reviewing LC-MS/MS analysis.
Essential Functions
- GLP and Non-GLP (non-routine) reports
- Review of data and reports for compliance and accuracy
- Support for Quality Assurance Unit
- Knowledge of technical/regulatory procedures and GLP regulations
- Monitoring of all GLP and Non-GLP studies schedules and timely tracking of related data phase and report audits and item closeouts.
- Protocols
- Review of all protocols for compliance and accuracy
- Assure that the protocol assigned to a study is current
- File copy protocols - requisition updates when necessary and maintain ongoing active review of procedures
- Standard Operating Procedures
- Develop and update assigned SOPs
- Audit implementation and compliance of SOPs
- Assist in monitoring yearly review, update and development of Toxicology SOPs, quality system audits, compilation of ISO data for management review.
- Audits
- Conduct phase, raw data and report audits
- Participate in Regulatory and Sponsor audits, as required
- Assist with internal audits (ISO/GLP) and related reporting
- Sponsor interaction on quality issues related to toxicology and PChem studies
- Documentation
- Review of all new data or procedural documentation formats
- Review of: All related views for Non-GLP and GLP studies, including phase audits. Auditing of computer systems vs. printed material.
- Review and assist as required in log-in and archiving activity audits thereof
- Equipment Calibration
- Review of records (monthly) and historical file maintenance
- Ensure accuracy of Equipment SOP Distribution Lists
- Ensure availability and use of Preventative Maintenance Logs
- Interface with technical, sales and marketing, administrative departments related to quality assurance issues
- Assist in the updating of ISO 9000-quality systems program
- Submit status reports related to system and performance audits of the laboratory to management and study directors
- Maintain conformance with Toxikon's quality mission statement, goals and values. Enforce and maintain compliance with ISO 9001 certification through the laboratories and operations.
- Assist management in special projects and quality management thereof.
Candidates can forward their resumes to John Duffy at hr@toxikon.com or visit our website at www.toxikon.com
