Specialist 3, Document Control

2 weeks ago

Irvine, United States Western Digital Full time

**Company Description**
At Western Digital, our vision is to power global innovation and push the boundaries of technology to make what you thought was once impossible, possible.

At our core, Western Digital is a company of problem solvers. People achieve extraordinary things given the right technology. For decades, we’ve been doing just that. Our technology helped people put a man on the moon.

We are a key partner to some of the largest and highest growth organizations in the world. From energizing the most competitive gaming platforms, to enabling systems to make cities safer and cars smarter and more connected, to powering the data centers behind many of the world’s biggest companies and public cloud, Western Digital is fueling a brighter, smarter future.

Binge-watch any shows, use social media or shop online lately? You’ll find Western Digital supporting the storage infrastructure behind many of these platforms. And, that flash memory card that captures and preserves your most precious moments? That’s us, too.

We offer an expansive portfolio of technologies, storage devices and platforms for business and consumers alike. Our data-centric solutions are comprised of the Western Digital®, G-Technology, SanDisk® and WD® brands.

Today’s exceptional challenges require your unique skills. It’s You & Western Digital. Together, we’re the next BIG thing in data.
**Job Description** Job Description**:

- Prepares program documentation for release (BOMs, Specs, AW, Tech pubs, etc)
- Assist various team members (Marketing, NPI, etc) in part number assignment
- Create Finished Good (SKU) part number for all Consumer Solutions products
- Create and release BOMs (Bills of Material)
- Review and Process Agile changes from submission to implementation
- Creates all types of Agile objects (Change Requests and Orders, Deviations, Parts, Programs)
- Review and analyze proposed changes and work with Core Teams
- Facilitate finding resolution for ECO/EDO ‘Condition & Reject’ completeness.
- Participate in Cross-Functional team meetings to create and document new processes
- Provide training and user reference materials for Agile users
- Manage Approval Matrix (approvers, acknowledgers, observers and notification)
- Create unique customer configuration requirements and release supporting documentation for production
- ODM management of BOMs and Engineering Change Requests (ECRs)
- Banned Countries - Restrict orders/shipments to banned countries due to certification

**Qualifications** Skills**:

- Detail-Oriented - assess the accuracy of documents, and prepare soft copies, need to be able to spot problems and errors, and resolve any queries with the appropriate department.
- Interpersonal Skills - this role requires to work with a range of different people, from internal departments to external business/ODM partners, so strong communication skills are essential (both verbal and written)
- Computer Skills - Document Control specialist will spend a large proportion of their time using computers, so they need to have great typing skills and be able to pick up software and programs quickly, including Microsoft Office products (Excel, PowerPoint, Word, Outlook)

**Additional Information**

Western Digital thrives on the power and potential of diversity. As a global company, we believe the most effective way to embrace the diversity of our customers and communities is to mirror it from within. We believe the fusion of various perspectives results in the best outcomes for our employees, our company, our customers, and the world around us. We are committed to an inclusive environment where every individual can thrive through a sense of belonging, respect and contribution.

LI-AJ1

**Compensation & Benefits Details**
- An employee’s pay position within the salary range may be based on several factors including but not limited to (1) relevant education; qualifications; certifications; and experience; (2) skills, ability, knowledge of the job; (3) performance, contribution and results; (4) geographic location; (5) shift; (6) internal and external equity; and (7) business and organizational needs.
- The salary range is what we believe to be the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range and this range is only applicable for jobs to be performed in California, Colorado, New York or remote jobs that can be performed in California, Colorado and New York. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid vacation time; paid sick leave; medical/dental/vision insurance; life, accident and disability insurance; tax-advantaged flexible spending and health savings accounts; employee assistance program; other voluntary benefit programs such as supplemental life and AD&D, legal plan, pet insurance, critical illness, accident and hospital indemnity; tuition reimbursement; transit; th

  • Documentation Specialist

    6 days ago

    Irvine, United States QuinTalent Inc Full time

    Documentation Specialist - Temp - 9 months 7am - 330pm onsite. Pay rate $27/hr This position is for an entry-level Documentation Specialist who will be responsible for supporting the manufacturing of products by creating/processing/reviewing production batch records following established GDP/GMP processes and procedures. **How You'll Make An Impact**: -...

  • Documentation Specialist

    4 weeks ago

    Irvine, United States Tucker Parker Smith Group (TPS Group) Full time

    Documentation Specialist Location: Irvine, CA Hours: 7:00 AM - 3:30 PM, OnsitePay Rate: $27/hr.9 month contract (Great potential to extend or convert)On behalf of our client a pharmaceutical company focused on the development of medical devices for the life science industry. We are seeking an Entry-Level Documentation Specialist to join their team in Irvine,...

  • Documentation Specialist

    4 weeks ago

    Irvine, United States Cypress HCM Full time

    Documentation SpecialistThe Documentation Specialist who will be responsible for supporting the manufacturing of products by creating, processing and reviewing production batch records. The Doc Specialist will follow established GDP & GMP processes and procedures.Summary:Review documents for format, accuracy and compliance with existing procedures; provide...

  • Documentation Specialist

    4 weeks ago

    Irvine, United States Cypress HCM Full time

    Documentation SpecialistThe Documentation Specialist who will be responsible for supporting the manufacturing of products by creating, processing and reviewing production batch records. The Doc Specialist will follow established GDP & GMP processes and procedures.Summary:Review documents for format, accuracy and compliance with existing procedures; provide...

  • Documentation Specialist

    6 days ago

    Irvine, United States Cypress HCM Full time

    Job DescriptionJob Description Documentation SpecialistThis position is for an entry-level Documentation Specialist who will be responsible for supporting the manufacturing of products by creating/processing/reviewing production batch records following established GDP/GMP processes and procedures. Summary:Reviews documents for format, accuracy and compliance...

  • Document Control Associate

    4 weeks ago

    Irvine, United States Biomerica, Inc. Full time

    **Document Control Associate (IVD Medical Device, Immunoassay)** **Biomerica Irvine, CA USA** At Biomerica, we improve lives by developing, manufacturing and marketing products designed to enhance the health and well-being of people, while reducing healthcare costs. We are a team of talented individuals with diverse backgrounds and expertise, working...

  • Documentation Specialist

    6 days ago

    Irvine, United States Synergy Solutions Full time

    Initial 9 month contract with possible extension and/or conversion to permanent employment. 7am - 330pm onsite, Monday to Friday This position is for an entry-level Documentation Specialist who will be responsible for supporting the manufacturing of products by creating/processing/reviewing production batch records following established GDP/GMP processes...

  • Jr Documentation Specialist

    4 days ago

    Irvine, United States TCWGlobal Full time

    Jr Documentation Specialist (Pharma, Biotech, Medical Device)Irvine, CA 92618 (Local candidates only. Onsite)$27hr (Weekly pay + Benefits)9 months contract (Excellent potential for permanent)Full- time: M-F 7am-3:30pm Our client is a global team of innovators, leaders, creators, builders, and problem solvers. They develop state-of-the-art instruments and...

  • Jr Documentation Specialist

    6 days ago

    Irvine, United States TCWGlobal Full time

    Job DescriptionJob DescriptionJr Documentation Specialist (Pharma, Biotech, Medical Device)Irvine, CA 92618 (Local candidates only. Onsite)$27hr (Weekly pay + Benefits)9 months contract (Excellent potential for permanent)Full- time: M-F 7am-3:30pmOur client is a global team of innovators, leaders, creators, builders, and problem solvers. They develop...

  • Jr Documentation Review Specialist

    6 days ago

    Irvine, United States TCWGlobal Full time

    Job DescriptionJob DescriptionJr Documentation Review Specialist (Pharma, Biotech, Medical Device)Irvine, CA 92618 (Local candidates only. Onsite)$27hr (Weekly pay + Benefits)9 months contract (Excellent potential for permanent)Full- time: M-F 7am-3:30pm  Our client is a global team of innovators, leaders, creators, builders, and problem solvers. They...

  • Jr Documentation Review Specialist

    4 days ago

    Irvine, United States TCWGlobal Full time

    Jr Documentation Review Specialist (Pharma, Biotech, Medical Device) Irvine, CA 92618 (Local candidates only. Onsite)$27hr (Weekly pay + Benefits)9 months contract (Excellent potential for permanent)Full- time: M-F 7am-3:30pm Our client is a global team of innovators, leaders, creators, builders, and problem solvers. They develop state-of-the-art instruments...

  • Jr Documentation Review Specialist

    3 days ago

    Irvine, United States TCWGlobal Full time

    Jr Documentation Review Specialist (Pharma, Biotech, Medical Device) Irvine, CA 92618 (Local candidates only. Onsite)$27hr (Weekly pay + Benefits)9 months contract (Excellent potential for permanent)Full- time: M-F 7am-3:30pm Our client is a global team of innovators, leaders, creators, builders, and problem solvers. They develop state-of-the-art instruments...

  • Document Services Associate

    4 days ago

    Irvine, United States Pacific Premier Bank Full time

    The Document Services Associate performs document Quality Control review, utilizing the banks taxonomy as a guide. Verifies that documents in PPBI’s system of record are in the proper placeholder; on the correct loan; dated correctly; pages rotated correctly; separate documents as needed; and remove duplicate documents. Responsible for document...

  • Documentation Specialist Ii

    5 days ago

    Irvine, United States QuinTalent Inc Full time

    Hybrid Monday-Friday 8am-5pm 3 days on site Tuesday,Thursday and one other day 1 year contract, **No fully remote** and $40-45/hr all inclusive rate. Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all our client's products currently CE Marked under the IVD Directive. Activities include preparation revision of...

  • Quality Control Specialist

    5 days ago

    Irvine, United States ITT, Inc. Full time

    Position Summary: This role is responsible for performing inspection tasks related to in-process, Final and/or Receiving Inspection areas. Essential Responsibilities: - Perform Inspection on all products within a timely manner - Determine product conformance or non-conformance to drawings - Use SAP to transact product to inventory or to MRB - Write...

  • Senior Specialist, Regulatory Affairs

    7 days ago

    Irvine, United States Orange County Regulatory Affairs Discussion Group (OCRA) Full time

    Senior Specialist, Regulatory Affairs, Sustaining Products, THV The Regulatory Affairs Senior Specialist role is an outstanding opportunity to be a part of the Edwards Lifesciences Transcatheter Heart Valve (THV) program, one of the medical device industry’s most groundbreaking technological innovations. Edwards has a strong pipeline in this space and the...

  • Specialist, Clinical Affairs

    2 days ago

    Irvine, United States Jenavalve Technology Inc Full time

    **Job Title**: Specialist, Clinical Affairs **Supervisor/Manager Title**:Senior** **Manager, Clinical Affairs **Job Description Summary**:Supports Clinical Research Associates (CRAs) to manage specific activities related to clinical projects. **Responsibilities**: - Provides support to CRAs who are conducting site visits, as needed. - Serves as quality...

  • Senior Regulatory Affairs Specialist

    1 week ago

    Irvine, United States Infosoft, Inc. Full time

    Job Title: Senior Regulatory Affairs SpecialistDuration: 9 monthsLocation: Irvine, CA (Onsite)Shift: 8 am to 5 pm.Our Client is a Global medical device Manufacturer.We are looking for a Senior Regulatory Affairs Specialist to complete and maintain regulatory approvals and clearances of assigned products.Create regulatory submissions (exercising judgment to...

  • Senior Regulatory Affairs Specialist

    1 week ago

    Irvine, United States Infosoft, Inc. Full time

    Job Title: Senior Regulatory Affairs SpecialistDuration: 9 monthsLocation: Irvine, CA (Onsite)Shift: 8 am to 5 pm.Our Client is a Global medical device Manufacturer.We are looking for a Senior Regulatory Affairs Specialist to complete and maintain regulatory approvals and clearances of assigned products.Create regulatory submissions (exercising judgment to...

  • Senior Regulatory Affairs Specialist

    1 week ago

    Irvine, United States Infosoft, Inc. Full time

    Job Title: Senior Regulatory Affairs SpecialistDuration: 9 monthsLocation: Irvine, CA (Onsite)Shift: 8 am to 5 pm.Our Client is a Global medical device Manufacturer.We are looking for a Senior Regulatory Affairs Specialist to complete and maintain regulatory approvals and clearances of assigned products.Create regulatory submissions (exercising judgment to...