Job Title: Conformance & GMP Projects Specialist
Location: Berkeley, CA
Zip Code: 94710
Start Date: ASAP
Job Type: Contract
Schedule: Hybrid - 2 days in office
Keywords: #projectmanagement #conformancespecialistjobs #CAjobs


JOB RESPONSIBILITIES:
* 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.

REQUIRED QUALIFICATIONS:
* Minimum Education B.S. degree in a Science related field, i.e. Engineering, Biology, Chemistry, etc.
with 6+ years of experience OR
* 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.

PREFERRED QUALIFICATIONS:
* 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)

If you are interested in this role, please apply via the apply now link provided. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract, temporary, temp-to-hire, and direct assignments. We are the employer of choice for thousands worldwide. For more information, please visit our website at Belcan.com
EOE/F/M/Disability/Veterans