Validations Documentation Specialist in Santa Rosa, CA at APEX Systems

Date Posted: 8/16/2019

Job Snapshot

Job Description

Job #:  988606
The position of Validations Documentation Specialist is with a Toxicology Laboratory located at Santa Rosa, CA. Primary duties include documentation of validation projects for laboratory testing methodology for the determination of drugs and metabolites in biological matrices. This role will instrumental in providing accurate and timely test results to our clients. 
This job description will be reviewed periodically and is subject to change by management. 

RESPONSIBILITIES: 

• Data entry of validation results 

• Performing basic statistical analysis with Microsoft Excel 

• Analyzing data from validation batches 

• Writing validation plans and reports that meet Quality System requirements 

• Review of Standard Operating Procedures and Validation Reports to ensure consistency 

• Support production team with documentation review. 

• Present project results and recommendations to department management 

• Proactively and cooperatively communicate with peers and management to ensure awareness of progress and issues; recommend solutions when issues arise 

• Maintain and meet the highest standards in quality and regulatory compliance. 

• Follow, understand and comply with SOP’s and policies on cGLP’s and safety. 

• Perform any other duties as designated by the Manager, Technical and Instrumentation or dictated by the needs of the laboratory 
BASIC QUALIFICATIONS/EDUCATION: 

• Bachelor’s degree from an accredited college or university in a physical or life science and 2 years of experience. 
PREFERRED QUALIFICATIONS: 

• Experience with Microsoft Word, Excel and Powerpoint. 

• Experience preparing documents for QC/QA departments 

• Experience with electronic document control systems such as Agile. 

• Strong background in statistics is highly desirable. 

COMPETENCIES: 
Achieving results
 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.