Computerized Systems Validation BSA

2 weeks ago

Alameda, United States TRUGlobal Full time

This is Karthik from TRuGlobal. TRuGlobal is looking for a strong Sr.Business Analyst for a Onsite position in Alameda, Please reply back with the updated resume if you re interested with below position to

Position Details:

Title: Sr. Business Analyst -level III

Location: Alameda, CA Onsite

Type of position: 6+ Months Contract-to- Hire OR Full-time

Direct Client

General Summary:

The Sr Business Systems Analyst will assure that validated computerized systems are implemented, maintained, and obsoleted in a state of compliance. Assess the performance of regulated systems. Lead, drive and own projects and ensure effective communications and cross collaborations with the business on various Computerized Systems Validation initiatives and projects. Any communications or cross collaborations with the business are to be done by Level III and above. The Sr level will also work closely with the Manager to assist with training and mentoring more junior level CSVS and Business Analyst.

Essential Duties and Job Functions General responsibilities for this position will include (but are not limited to) the following:

Work closely with management to support other quality engineering initiatives to drive them down throughout the team.

  • Work on multiple projects and meet timelines, requiring expert multitasking skills and ability to prioritize work effectively.
  • Create documentation to support the design and development of solutions, such as, but not limited to, user stories, business/product requirements documents (BRD/PRD), functional and non-functional specifications and documentation (FRD), acceptance criteria, product roadmaps, and to-be process flows and traceability matrices, meeting notes, gap analysis, etc.
  • Adhere to the Company s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
  • Manage and execute the deviation process during execution of testing. Author deviation form content. Work with the customer to resolve deviations recorded during test execution or system modifications.
  • Apply knowledge of quality engineering principles to ensure compliance with regulatory requirements and impart that knowledge to junior level CSVS.
  • Work closely with the SWQ Manager to collaborate with cross functional team to identify, prioritize and execute business critical quality initiatives.
  • Ensure other members of the department follow the QMS, regulations, standards, and procedures.
  • Manage conflict resolutions both transparently and proactively by continually informing manager, team, and client of progress, issues, and concerns.
  • Work with end-users across the organization, to gather, understand, prioritize, and define business requirements, leveraging Medical Device, Pharmaceutical experience and best-practice methods and collaborating and seeking guidance from stakeholders.
  • Provide quality support to development, engineering and manufacturing functions for design control and transfer activities.
  • Facilitate and participate in internal development team s quality reviews of requirements to ensure they are complete, consistent, comprehensible, feasible, and conform to standards and align with client business objectives.
  • Drive/assist the development of business strategies, as appropriate, to guide clients and inform requirements.

Position Qualifications

Minimum education and experience:

  • Bachelor s degree required, in engineering, computer science, or related discipline with 12+ years related experience, preferably in the medical device, pharmaceutical, or similar FDA-regulated industry, or an equivalent combination of education and experience.
  • Required to have advanced knowledge of Quality Engineering Principals and Regulatory Environment such as: 21CFR11, 21CFR820, Annex 11, ISO 13485, 21CFR210, 21CFR212, HIPAA/PHI, SOX, GDPR
  • Experience with the installation, configuration, validation, and maintenance of regulated software such as Quality Management Systems, Learning Management Systems, and Clinical Trial Management Systems
  • Expert knowledge of GAMP guidelines, 21 CFR Part 11, and FDA requirements and expectations for validated systems preferred.
  • Strong oral, written and interpersonal communication skills.
  • Strong leadership skills with ability to work effectively within a cross-functional team.
  • Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously.
Computerized Systems Validation BSA

  • System Validation Engineer

    1 month ago

    Alameda, United States The Fountain Group Full time

    Job DescriptionJob Description100% onsite in Alameda CAPay: $43-$48/hrRequired:BS in Electrical Engineering or Computer Science2+ years of experience with system architecture, data modeling/algorithm, and software integration, testing tools and methodologies, validation of embedded systems, and Proficiency in scripting languages (e.g., Python, SQL) for...

  • Validation Lead

    1 month ago

    Alameda, United States I.T. Solutions, Inc. Full time

    Role: GxP Validation LeadLocation: Onsite at Alameda, CA (2-3 Days)Duration: Long Term Rolling Contract The Validation Lead will be the primary liaison between product and quality teams to help validate number of products. The role will leverage strategic mindset to transform and adopt a risk-based approach to move the client towards Software Assurance.Act...

  • Validation Lead

    1 month ago

    Alameda, United States I.T. Solutions, Inc. Full time

    Role: GxP Validation LeadLocation: Onsite at Alameda, CA (2-3 Days)Duration: Long Term Rolling Contract The Validation Lead will be the primary liaison between product and quality teams to help validate number of products. The role will leverage strategic mindset to transform and adopt a risk-based approach to move the client towards Software Assurance.Act...

  • Systems Integration Engineer

    4 weeks ago

    Alameda, United States Rethink Recruit Full time

    Job DescriptionJob DescriptionWebsiteCompany Overview:Kai Concepts is a Bay Area team, founded by Don Montague, known for testing the limits of kite propulsion, hydrofoil technology and experimenting with technological advances in water-sport technology. The company has strong backing from industry luminaries. We are a small team of creative problem solvers...

  • Systems Integration Engineer

    1 month ago

    Alameda, United States Rethink Recruit Full time

    Job DescriptionJob DescriptionWebsiteCompany Overview:Kai Concepts is a Bay Area team, founded by Don Montague, known for testing the limits of kite propulsion, hydrofoil technology and experimenting with technological advances in water-sport technology. The company has strong backing from industry luminaries. We are a small team of creative problem solvers...

  • Systems Engineer V

    13 hours ago

    Alameda, United States Abbott Laboratories Full time

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Working at...

  • Special Education Teacher

    1 month ago

    Alameda, United States ZSN Systems & Solutions Full time

    Job DescriptionJob DescriptionZSN System & Solutions is Hiring Special education teachers to work for the remaining School Year 2023-24 and the coming School Year 2024-25. in Alameda, CA, and other locations in California.Job Description:Age: High SchoolStart: March 1, 2024End date: June 7, 2024Total hours: 35-40 hrs per weekCredential & Qualification:Must...

  • Systems Engineer IV

    4 days ago

    Alameda, United States Abbott Laboratories Full time

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Working at...

  • Manager, Quality Systems

    1 week ago

    Alameda, United States Abbott Laboratories Full time

    Manager, Quality Systems - LINGOMeet Lingo, a new biosensing technology that provides users a window into their body. Lingo tracks key biomarkers – such as glucose, ketones, and lactate – to help people make better decisions about their health and nutrition. Biowearable technology will digitize, decentralize, and democratize healthcare, enabling...

  • Hair Stylist

    2 weeks ago

    Alameda, United States Aligned Systems LLC Full time

    Job DescriptionJob DescriptionHairdresser - RentSalon 1500Alameda, CA, USAEmployment TypeIndependent Contractor Hair StylistCompany Overview:We are a family-owned large salon with deep roots in the city of Alameda. With a commitment to excellent customer service and a collaborative team environment, we take pride in providing a top-tier salon experience for...

  • Hair Stylist

    2 weeks ago

    Alameda, United States Aligned Systems LLC Full time

    Job DescriptionJob DescriptionHairdresser - RentSalon 1500Alameda, CA, USAEmployment TypeIndependent Contractor Hair StylistCompany Overview:We are a family-owned large salon with deep roots in the city of Alameda. With a commitment to excellent customer service and a collaborative team environment, we take pride in providing a top-tier salon experience for...

  • Retail Key Holder PT

    6 days ago

    Alameda, United States SalonCentric Full time

    Alameda, CA Posted: 04/03/2024DescriptionSalonCentric Key Holder - Part TimeDo you have a passion for people and delivering exceptional customer service?Do you seek out exciting new products and training opportunities to become an expert in the hair and beauty industry?Do you love hair and beauty products? If you answered YES, apply today for our Retail...

  • Retail Key Holder PT

    5 days ago

    Alameda, United States L Oreal USA Full time

    SalonCentric Key Holder - Part TimeDo you have a passion for people and delivering exceptional customer service?Do you seek out exciting new products and training opportunities to become an expert in the hair and beauty industry?Do you love hair and beauty products?If you answered YES, apply today for our Retail Sales Associate Position!SalonCentric, a...

  • Director of Technology

    4 days ago

    Alameda, United States First 5 Alameda Full time

    The Director of Technology works closely with First 5 Alameda County (Agency) leadership and staff ensuring technological infrastructure reliability and efficiency and aligning technology initiatives with the agency’s mission. This role provides strategic leadership, direction and execution for all aspects of technology and related matters for computerized...

  • Retail Key Holder PT

    7 days ago

    Alameda, United States SalonCentric Full time

    Alameda, CA Posted: 04/03/2024 Description SalonCentric Key Holder - Part Time Do you have a passion for people and delivering exceptional customer service? Do you seek out exciting new products and training opportunities to become an expert in the hair and beauty industry? Do you love hair and beauty products? If you answered YES, apply today for our...

  • Mechanical Engineer

    1 month ago

    Alameda, United States Navier Full time

    Navier is building the boat of the future! We are a fast-growing startup in the maritime space led by MIT engineers with a passion for boating and electric transportation. Our DNA is one part maritime, one part Silicon Valley tech and one part aerospace. Our first product, Navier 30, is an electric hydrofoil speed boat that is more than 10 times as efficient...

  • Director R&D Data Engineering, Data Analytics

    1 month ago

    Alameda, United States Abbott Laboratories Full time

    The Director R&D Data Engineering, Data Analytics develops and participates in setting the strategy and tactical direction of the R&D Data Engineering organization to ensure the organization carries out its function effectively and efficiently in alignment with the objectives of the business.  This leader will set organization goals, ensure that they are...

  • Quality Engineering Manager

    5 days ago

    Alameda, United States Penumbra Full time

    In a pivotal role on our quality engineering team, you will be the driving force behind the quality of some of Penumbra's most innovative products. You will provide leadership and drive results in all aspects of product development and manufacturing in order to ensure the highest level of quality in new and existing products, and their compliance to...

  • Quality Engineering Manager

    7 days ago

    Alameda, United States Penumbra Full time

    In a pivotal role on our quality engineering team, you will be the driving force behind the quality of some of Penumbra's most innovative products. You will provide leadership and drive results in all aspects of product development and manufacturing in order to ensure the highest level of quality in new and existing products, and their compliance to...

  • IT Support Technician

    1 week ago

    Alameda, United States City Of Alameda Full time

    **Nature of Position**: Under general supervision, the **IT** Support Technician** **provides enterprise technology systems support and performs other related work as required. This is a part time opportunity and typically employees are scheduled for a maximum of 28 hours per week. Position will be in the IT department, with no opportunity for remote...