Dexian
Quality Assurance Project Manager
Dexian, Berkeley, California, United States, 94709
Job Title: Quality Project ManagerLocation: Berkeley, CADuration: 6+ monthsPay Range: $45-53/hrLocal Candidates only- Hybrid role on site 2 times per weekDEPARTMENT/TEAM DESCRIPTION:
POSITION SUMMARYFocus is internal. Leads cross-functional teams and interfaces with external groups on tasks/assignments relating to deviation and change management. Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions.DUTIES & RESPONSIBILITIESDeviation ManagementInvestigate discrepancies using root cause analysis (RCA) methodologies. Recommend corrective/preventative actions (CAPAs) based on root cause investigations to eliminate recurrence.Lead multi-discipline teams to complete investigations, or for the purpose of Continuous ImprovementInfluences direction of investigations and communicates with all levels of employeesWrite concise, accurate and effective deviation reports for investigations that meet compliance expectationsChange ManagementCoordinate and manage change applications (Local and Global).Maintain alignment of Global Standard Operating procedures (GSOP) and Operational Instructions (GOI) to local procedures.Support CMS Chapter Owners and Representatives by maintaining compliance. Update and upgrade CMS Chapters.Support process development/improvement projects, site-wide and global projects.REQUIREMENTS/PREFERENCESEducation Requirement(s):Minimum Education B.S. degree in a Science related field, i.e. Engineering, Biology, Chemistry, etc.Minimum Experience BS 6+ yearsMS 0-4+ years of experience in a related field such as: Engineering, Quality, or Manufacturing in the pharmaceutical industry or an equivalent combination of education and experienceSkill & Competency Requirements:
(list 3 to 5 non-negotiable items such as years of experience, industry of preference, specific knowledge items, professional certifications, skills, abilities, etc.)MUST have experience/expertise in cell and gene therapy manufacturingKnowledge and hands-on experience with pharmaceutical manufacturing processes, including equipment, utilities, and facilities, cGMP compliance, high purity water systems, HVAC systems, process instrumentation and control systems, etc.Experience with regulatory and cGMP requirements for pharmaceutical manufacturingStrong analytical skills to identify root causes and prepare balanced decisionsAbility to plan and prioritize complex and conflicting activities; act in a speedy and pragmatic manner, adapt quickly to changing environments, without sacrificing quality and long-term goals.Strong written and verbal communication skills, and effective presentation skills and ability to adjust presentation style to accommodate various audiences.Preferences: (list nice-to-haves such a specific knowledge items, certifications, skills, abilities, etc.)SAP, ValGenesisDeviation Management/Quality Management Software (e.g. Trackwise, Sparta, Werum Pas-X)Risk AssessmentsAuthoring/Reviewing Documents for Regulatory ReviewLean Six Sigma and Continuous Improvement MethodologyProject Management Professional (PMP)Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals.Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more.Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
POSITION SUMMARYFocus is internal. Leads cross-functional teams and interfaces with external groups on tasks/assignments relating to deviation and change management. Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions.DUTIES & RESPONSIBILITIESDeviation ManagementInvestigate discrepancies using root cause analysis (RCA) methodologies. Recommend corrective/preventative actions (CAPAs) based on root cause investigations to eliminate recurrence.Lead multi-discipline teams to complete investigations, or for the purpose of Continuous ImprovementInfluences direction of investigations and communicates with all levels of employeesWrite concise, accurate and effective deviation reports for investigations that meet compliance expectationsChange ManagementCoordinate and manage change applications (Local and Global).Maintain alignment of Global Standard Operating procedures (GSOP) and Operational Instructions (GOI) to local procedures.Support CMS Chapter Owners and Representatives by maintaining compliance. Update and upgrade CMS Chapters.Support process development/improvement projects, site-wide and global projects.REQUIREMENTS/PREFERENCESEducation Requirement(s):Minimum Education B.S. degree in a Science related field, i.e. Engineering, Biology, Chemistry, etc.Minimum Experience BS 6+ yearsMS 0-4+ years of experience in a related field such as: Engineering, Quality, or Manufacturing in the pharmaceutical industry or an equivalent combination of education and experienceSkill & Competency Requirements:
(list 3 to 5 non-negotiable items such as years of experience, industry of preference, specific knowledge items, professional certifications, skills, abilities, etc.)MUST have experience/expertise in cell and gene therapy manufacturingKnowledge and hands-on experience with pharmaceutical manufacturing processes, including equipment, utilities, and facilities, cGMP compliance, high purity water systems, HVAC systems, process instrumentation and control systems, etc.Experience with regulatory and cGMP requirements for pharmaceutical manufacturingStrong analytical skills to identify root causes and prepare balanced decisionsAbility to plan and prioritize complex and conflicting activities; act in a speedy and pragmatic manner, adapt quickly to changing environments, without sacrificing quality and long-term goals.Strong written and verbal communication skills, and effective presentation skills and ability to adjust presentation style to accommodate various audiences.Preferences: (list nice-to-haves such a specific knowledge items, certifications, skills, abilities, etc.)SAP, ValGenesisDeviation Management/Quality Management Software (e.g. Trackwise, Sparta, Werum Pas-X)Risk AssessmentsAuthoring/Reviewing Documents for Regulatory ReviewLean Six Sigma and Continuous Improvement MethodologyProject Management Professional (PMP)Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals.Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more.Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.