Sr. Analytical Scientist - Vista, CA | Biospace
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Sr. Analytical Scientist

Bachem

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Location:
Vista, CA
Posted Date:
11/17/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Validation,

Job Description

ESSENTAIL FUNCTIONS AND RESPONSIBILITIES

•   Maintain the Quality Control laboratories and stability program per FDA cGMP parts 210 and 211, ICH Q7 and Q9 requirements for drug substances and ISO 13485 for raw materials used in device and diagnostics  

•   Develop annual master analytical validation plan and ensure validations are conducted per ICH guidelines, including cleaning validations and analytical test method validation

•   Ensure continuous improvement and effectiveness of the quality control labs

•   Oversee and conduct cGMP, ICH and ISO stability programs to comply with regulatory requirements

•   Oversee work of direct reports; distribute workload, and cross-train staff on different quality areas. Interview, hire, train, develop and manage employees

•   Oversee the document control function, including issuing records, maintaining electronic and hard copies of master records, and maintaining hard copies of history records

•   Investigate and document out-of-specification results and deviations during product testing

•   Assure and oversee testing and raw materials, ensure safe, secure, and documented storage of final products in GMP manufacturing

Requirements

REQUIRED:

•   A college degree specializing in chemistry or biochemistry
•   At least 5 years’ experience in a GMP laboratory setting
•   At least 5 years’ experience spent in method development/validation activities
•   A strong working knowledge of analytical chemistry and chromatographic theory and principles
•   Thorough knowledge cGMP regulations and FDA guidelines
•   Exhibit detail oriented documentation skills
•   Ability to follow directions
•   Ability to effectively organize, multitask and work in a fast-paced, deadline drive work environment
•   Excellent written and oral communication skills
•   Ability to communicate in a proactive and solutions-focused manner, including keeping management aware of potential issues
•   Ability to work independently and manage one’s time
•   Basic computer knowledge, including Microsoft Word and Excel (used daily)
•   Proficiency with Waters Empower software

PREFERRED:

•   Technical experience includes MS, GC, and/or UV/Vis Spectroscopy
•   Previous experience working with proteins or peptides
•   Proficiency with Waters Empower software and Thermo-Dionex Chromeleon software