QA Specialist II in South San Francisco, CA at APEX Systems

Date Posted: 2/14/2020

Job Snapshot

Job Description

Job #:  1048539
Apex Systems is looking for a QA Specialist for one of our large biotech clients in South San Francisco, CA. If you are interested in applying for this opportunity, please reach out to recruiter Ashlyn Hardman at ahardman@apexsystems.com
   
Duties: Provide on-the-floor day to day Quality support to clinical packaging and warehousing operations.
Perform routine Manufacturing Quality Assurance tasks, including labeling printing approval, line clearance, QC sampling, and AQL inspection to support clinical packaging and lot release.
Perform final review of manufacturing batch records manufactured cell banks and clinical large molecule drug substance, drug product and final drug product.
Compile Batch History Records for Product Manager review.
Scan documents into our GMP document management system.
Review and Interact with interdepartmental contacts on discrepancy assessment, resolution, and quality approval.
Provide Quality oversight to internal customers in the Manufacturing organization.
Collaborate with departments to ensure that all review activities are executed efficiently and effectively.
Make independent decisions around complex issues in alignment with GNE policies.
Identify and implement process improvements, as necessary.
   
Skills: Thorough knowledge of cGMPs (Drugs and Biologics), and regulations applicable to U.S. and international Regulatory agencies. Knowledge of cGMPs or equivalent regulations strongly preferred Ability to interpret Quality standards for implementation Ability to independently evaluate situations and propose potential solutions Ability to interpret Quality standards for implementation Ability to communicate clearly and professionally both in writing and verbally Flexibility in problem solving and work hours to meet business objectives Knowledge of SAP and Trackwise applications and project management skills are highly desirable.  
Education: BS/BA degree in the life sciences plus 5-7 years experience. A minimum of at least 5 years experience in Quality Assurance, Quality Control, Manufacturing, or equivalent experience.
 
 
 
 
 
 
 
 
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.