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location: Berkeley, California
job type: Contract
salary: $46.65 - 54.88 per hour
work hours: 8 to 4
education: Bachelors
responsibilities:
POSITION SUMMARY
Focus 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.
POSITION DUTIES & RESPONSIBILITIES
Deviation Management
- Investigate 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 Improvement
- Influences direction of investigations and communicates with all levels of employees
- Write concise, accurate and effective deviation reports for investigations that meet compliance expectations
- Coordinate 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.
qualifications:
REQUIREMENTS/PREFERENCES
Education Requirement(s):
- Minimum Education B.S. degree in a Science related field, i.e. Engineering, Biology, Chemistry, etc.
- Minimum Experience BS 6+ years
- MS 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 experience
MUST have experience/expertise in cell and gene therapy manufacturing
- Knowledge 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 manufacturing
- Strong analytical skills to identify root causes and prepare balanced decisions
- Ability 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.
- SAP, ValGenesis
- Deviation Management/Quality Management Software (e.g. Trackwise, Sparta, Werum Pas-X)
- Risk Assessments
- Authoring/Reviewing Documents for Regulatory Review
- Lean Six Sigma and Continuous Improvement Methodology
- Project Management Professional (PMP)
- None
skills: SOP, PMP, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
