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Quality Assurance Specialist
Ref No.: 18-14978
Location: South San Francisco, California
Job Title: Quality Assurance Specialist
Job Company: Major BioPharma
Job Location: South San Francisco, CA
Job Duration: 3+ mos contract; Special Project, Contractor is required to support on-going work in Quality Systems and Business Processes in IMP External Quality


Job Description:
Quality Systems and Business Processes
 
Position: Quality Systems and Business Processes
The purpose of this position in Quality Systems and Business Processes is to support the global External Quality Development (IMP) organization in providing Quality oversight to Contract Manufacturing Organizations (CMOs), Clinical Research Organizations (CROs) and Partners, as well as internal stakeholders.
 
This position will be based in South San Francisco and reports to the Head of Quality Systems and Business Processes, External Quality Development (IMP).
 
Job Responsibilities:
  • Actively contribute to the development and implementation of Standard Operating Process/Procedures, Tools and Templates in External Quality Development (IMP).
  • Lead or participate in department and cross-functional continuous improvement projects and drive implementation of best practices.
  • Support the authoring and revisions of Standard Operating Procedures and guidance documents.
  • Lead or participate in Quality initiatives, as assigned.
  • Identify and participate in the resolution of Quality issues by fostering effective interdepartmental and cross-functional relations.
  • Work globally with other COMPANY groups to harmonize and understand Quality Systems and Business Processes.
  • Prepare routine reports and trend analysis of Quality Ops Metrics.
  • Nurture and champion a continuous improvement mindset.
 
Job Requirements:
 
  • BA/BS in Life Sciences or equivalent.
  • At least 12 years of experience in Quality Assurance, Quality Control, Manufacturing in the biotechnology or pharmaceutical industry.
  • Strong knowledge of cGMPs, and regulations applicable to U.S. and international Regulatory agencies.
  • Demonstrate excellent problem solving skills using critical thinking and identifying appropriate solutions.
  • Excellent verbal and technical written communication skills.
  • Strong interpersonal skills, and negotiation skills are essential.
  • Familiarity with computer systems and ability to quickly become familiar with new software (e.g. Trackwise, SAP).
  • Leads project team members to effectively execute local and cross-functional projects.
  • Demonstrated experience in working effectively with local and global teams.
  • Greenbelt certification or knowledge of LEAN/Six Sigma desired.
 
Education:
Bachelors degree
Required
  • WRITING STANDARD OPERATING PROCEDURES
  • CGMPS
  • LIFE SCIENCES
  • PROBLEM SOLVING
  • QUALITY ASSURANCE
Additional
  • LEAN PRACTICES
  • EXCELLENT VERBAL AND WRITTEN COMMUNICATION SKILLS
  • TRACKWISE
  • METRICS