Senior Quality Assurance Engineer
4 weeks ago
Senior Quality Assurance Engineer - Medical Device San Jose, CA ref
Skills: Quality Assurance, Engineering, Medical Device, • Experience with FDA Quality System Regulations and ISO Standards (ISO 13485 and ISO 14971) is required, • Experience with non-conformances, CAPA, and Risk Management, • Experience in performing test method validation and Gage R&Rs;, • Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)
Job description Job insights Screening questions Candidate pipeline
Direct hire
Your referral reward 10%
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Estimate: $15,050
Guarantee period: 60 days
Senior Quality Engineer - cGMP
Over 3 months agoSan Jose, CA
Rani Therapeutics
Skills: Pharmaceutical or Biopharmaceutical experience, cGMP, Qualification activities, VHP, • Experience with FDA Regulations (21 CFR part 820, part 210 and part 211) and ISO Standards (ISO 13485 and ISO 14971
Job description Job insights Screening questions Candidate pipeline
If you post this job on a job board, please do not use company name or salary.
Experience level: Mid Level (5-8 yrs exp.) Experience required: 7 Years Education level: Bachelor’s degree Job function: Engineering Industry: Biotechnology Compensation: View salary Total position: 1 Relocation assistance: Yes Visa : US citizens, Greencard holders preferred
The Sr. Quality Assurance Engineer supports compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements. This position is responsible for activities ranging from product development through commercialization. This is a hands-on role where the Sr. Quality Engineer will apply diversified knowledge of engineering, quality principles and practices for pharmaceutical and combination products. This position requires technical expertise in Aseptic Techniques. The Senior Quality Engineer is responsible for performing a quality role for the aseptic manufacturing, quality systems and compliance in accordance with cGMP, related company SOP’s, federal laws, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products.
Requirements
Maintain and improve Rani Quality System in accordance with FDA Regulations and ISO 13485 requirements
Provide hands-on direction for aseptic process and cGMP manufacturing activities
Support quality assurance activities, including, but not limited to: Risk Management (FMEAs, HA), internal and external audits, NCMRs and CAPAs
Collaborate with cross functional teams Manufacturing, Engineering, Facilities to ensure adherence to cGMP guidelines
Conduct investigations for issues associated with audits, lot history records and complaints. Approve manufacturing and testing deviations and investigations
Evaluation and support for implementation of new processes, lead continuous improvement of aseptic / sterile processes
Lead and support qualification and validation of cGMP equipment, facilities, utility systems, analytical test methods, cleaning and manufacturing processes. These duties will include, but are not limited to: the implementation and documentation of these validations and their lifecycle management in compliance with FDA and EU regulations
Manage the deviation system, perform QA assessment of deviations and ensure that all assessments are completed, review and approve deviation reports
Assist in the review and approval of lot history records and test records
Conduct audits at CMO, testing operations and internal audits
Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ), summary reports, ensure qualifications are conducted in accordance with the Validation Master Plan
Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause
Lead the resolution of quality issues related to non-conformance reports and CAPAs
Develop and initiate sampling procedures and statistical process control methods
Address systemic quality issues with suppliers or internal groups
Evaluate product changes for qualification and validation requirements and assist in change implementations
Other duties/ activities may be necessary to support departmental or company goals
Education and Job Experience
Bachelor’s degree or higher in Chemistry, Biology, or equivalent scientific discipline
A minimum of 7 years quality assurance/engineering experience within the pharmaceutical or biopharmaceutical industry is required
cGMP experience is required
Experience with performing utility qualification activities for vaporized hydrogen peroxide (VHP) system is preferred Excellent communication skills both oral and written
Understands and applies comprehensive knowledge of quality and GMP principles. Maintains current understanding of global GMP regulations
Experience with FDA Regulations (21 CFR part 820, part 210 and part 211) and ISO Standards (ISO 13485 and ISO 14971) is required
Experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)
Skills and Specifications
Ability to motivate and influence people
Must possess the ability to handle multiple tasks with high attention to detail Organizing, planning, and problem-solving skills
Good interpersonal and communication skills
Ability to work as a part of a team
Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports
Ability to create and provide training
Good statistical and numerical ability
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