Overview
Senior Manager, Quality & Safety Improvement, Patient Safety Jobs in Pleasanton, CA at Kaiser Permanente
Job Summary
Cellipont Bioservices is growing, and we are looking for a QA Technician II, Operations who believes in the potential of bridging client’s discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level.
The QA Technician II, Operations will be responsible for monitoring systems and procedures to ensure compliance where applicable. The QA Technician II, Operations is responsible to provide Quality Assurance support real-time for GMP Manufacturing of master/working cell banks. This individual will be responsible for providing QA on the Floor oversight of manufacturing including observing critical processes and performing AQL visual inspection, executed GMP documentation review and supporting other QA functions as needed.
The Role
Performs QA On-the-Floor activities supporting client projects, including room release, auditing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing.
Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry best practices.
Review and dispositions executed batch records and supporting documentation for completeness, accuracy and compliance.
Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.
Participates in root cause analysis using methodologies, such as: fishbone, 5 whys, comparative analysis, etc.
Support the evaluation and lot disposition of cell therapies
Performs QA on the Floor activities supporting client projects, including room release, observing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing. Also perform Acceptable Quality Limit (AQL) visual inspection of drug product
Write and revise GMP documentation as necessary
Participate in site and corporate quality and process improvement initiatives.
Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices.
The Candidate
Bachelor’s Degree preferred with a minimum of 1-2 years of direct GMP industry experience
Knowledgeable and/or exposure manufacturing processes related to cell therapy
Creative individual with excellent analytical, trouble shooting, and decision-making skills
Ability to quickly learn new and novel manufacturing processes supporting new clients
Able to work in a team setting and independently under minimum supervision
Familiarity with electronic systems, including developing and producing reports using Microsoft Access and Excel
Intermediate knowledge of Microsoft Office and database management skills, organization, and record keeping skills required.
Clear problem-solving and decision-making skills
Ability to function well in a changing environment
Position Benefits
Opportunities for career growth within an expanding team
Defined career path and annual performance reviewfeedback process
Cross-functional exposure to other areas of within the organization
Robust benefit package designed for unique HealthWellness needs, including coverage for your furry family members
401K strong employer match
Tuition Reimbursement
Employee Referral Bonuses
Flexible work schedules and PTO based on role/level, increasing 1 PTO day each year and paid holidays
Gain experience in the cutting-edge cell therapy space
“At Cellipont Bioservices, we look for candidates with an innate desire to serve. Our “family” approach ensures you will get the mentorship you need to develop a satisfying career here!”
Notice to Agency and Search Firm Representatives
Cellipont Bioservices is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Cellipont Bioservices employee by a third-party agency and/or search firm without a valid writtensigned search agreement and will become the sole property of Cellipont Bioservices. No fee will be paid if a candidate is hired for this position because of an unsolicited agency or search firm referral. Thank you.
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Title: Senior Manager, Quality & Safety Improvement, Patient Safety
Company: Kaiser Permanente
Location: Pleasanton, CA
