Specialist, Quality Assurance (SIAL) in Carlsbad, CA at Apex Life Sciences

Date Posted: 8/7/2018

Job Snapshot

Job Description


Quality Assurance Specialist 

Carlsbad, CA 

M-F, 8am to 4:30pm No Travel. Our team needs three investigators with extensive experience. - Can work independently. - Need no more than 1 day of training to get up to speed on our systems/processes. - Have working knowledge of Trackwise. - Are able to close 3 - 5 investigations per week.

Determines the root cause and corrective action of investigations identified through various processes (i.e. batch record review). Ensures that investigations identify true root cause and appropriate corrective actions in order to prevent recurrence. 

Who you are: 
• Ability to write investigations for all areas within the facility (i.e. analytical services, manufacturing, warehouse, engineering, etc.) 
• Provides technical expertise to the site to ensure that investigation corrective and preventative actions are complete, thorough, accurate, and timely 
• Interface with people effectively and work well independently 
• Work with minimal supervision and identify problematic deviations upfront 
• Ability to produce results in a fast-paced environment to meet client deadlines 
• Ability to apply quality tools (Fishbone Diagrams, 5 Whys, etc.) 

Bachelor’s degree in life sciences or related scientific discipline 

• Previous experience working in pharmaceutical/GMP environment 
• Proven ability to conduct investigations, writing deviations and CAPA’s 
• Proven ability to apply quality tools (Fishbone Diagrams, 5 Whys, etc.) 
• Must have experience with Trackwise 

Essential and Critical Skills: 

• Good analysis, troubleshooting, investigation and communication skills, especially both written and verbal 
• Thorough understanding of the biopharmaceutical manufacturing process, current Good Manufacturing Practices and CAPA 
• Ability to put complex thoughts and issues into writing in such a manner than an educated, but uniformed reader can understand and make decisions based on the written investigation report 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl. 

The employee may be required to enter the clean room environment. 

The employee must have the ability to perform very complex tasks with attention to detail. 
 

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, 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 employeeservices@apexsystemsinc.com or 844-463-6178.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, 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 employeeservices@apexsystemsinc.com or 844-463-6178.