Jobs
>
San Diego

    Senior Labeling Specialist - San Diego, United States - BioPhase

    BioPhase
    BioPhase San Diego, United States

    2 weeks ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    1 year contract to hire | ONSITE San Diego, CA

    The Senior Labeling Specialist is responsible for carrying out the daily operations of the change management function as it pertains to product labeling, design control projects and device master records maintenance.

    Responsbilites:

    • Responsible for coordinating / processing product and process changes that range from simple to complex within an Electronic Data Management System.
    • Responsible for interfacing with intra / inter – departmental associates on change management.
    • Works with Manufacturing, Marketing, Purchasing and Regulatory to provide an initial analysis of implementation timing, potential scrap costs and quantities of new labeling to be ordered.
    • Assists labeling change owners and junior staff with the creation of design change plans. Responsible for updating design change logs and analyzing labeling changes for impact to Device Master Records.
    • Creates and maintains the Design History Files for assigned development projects per the approved procedures.
    • Review records for good DHF documentation practices, adherence to the DHF Document Change Control requirements and determine the need for Reference Pointer Forms.
    • Maintain the Master Action Item List and the DHF Index Responsible for file maintenance and record keeping Performs other duties & projects as assigned

    Qualifications:

    • Familiar with federal and other regulations, e.g. QSR's, ISO 13485, CMDR, IVDD
    • Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
    • Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
    • Must be able to work under minimal supervision
    • Ability to handle multiple projects simultaneously and to prioritize tasks
    • Ability to follow detailed instructions, maintain accurate records, complete assignments in a thorough, conscientious fashion while adhering to company procedures and QSR compliance.
    • Advanced knowledge of Microsoft Office applications (Word, Excel, PowerPoint and Visio)
    • Experience with Adobe Acrobat Professional.
    • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.
    • Follow all safety guidelines, manufacturing policies and procedures. Operate under QSR compliance.
  • Actalent

    Labeling Specialist

    1 week ago

    Actalent San Diego, United States Full time

    Description: · Execution of regulatory change control for device labels and package inserts for newly licensed products (systems include: Trackwise event tracking system) · Responsible for coordinating / processing product and process changes that range from simple to complex wit ...

  • Sharp Healthcare

    Inventory Specialist

    1 week ago

    Sharp Healthcare San Diego, United States

    [OSHA Forklift Certification - Various-Employee provides certificate · **Hours**: · **Shift Start Time**: · 7 AM · **Shift End Time**: · 4 PM · **AWS Hours Requirement**: · 8/40 - 8 Hour Shift · **Additional Shift Information**: · **Weekend Requirements**: · No Weekends · **On-Ca ...

  • Genalyte

    Regulatory Affairs Specialist

    3 weeks ago

    Genalyte San Diego, United States

    Here at Genalyte, you will find yourself working with talented individuals inspired by our vision, eager to make an impact on the patient experience, and who share a common goal of getting our technology into every physician's office. We have a great opportunity for a Regulatory ...

  • Optima Office

    Order Processing Specialist

    3 weeks ago

    Optima Office San Diego, United States

    : · Our client's rapidly growing business is in need of an **Order Processing Specialist**, based in San Diego CA.**_ This is a full-time, on-site position._** · **Responsibilities**: · - Own the drop-ship order processing workflow: quoting, order acknowledgement, vendor setup, p ...

  • Mentor Technical Group

    Laboratory Support Specialist

    1 week ago

    Mentor Technical Group San Diego, United States

    Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, ...

  • UC San Diego Health

    Front Desk/call Center Specialist Per Diem-float

    1 week ago

    UC San Diego Health San Diego, United States

    Payroll Title: · - HOSP AST 3 PD · - Department: · - FAC PRAC AMBULATORY FLOAT TEAM · - Hiring Pay Scale · - $32.99 / Hour · - Worksite: · - Lightwave Avenue · - Appointment Type: · - Per Diem · - Appointment Percent: · - 20% · - Union: · - EX Contract · - Total Openings: · - 1 · ...

  • Imperial Beach Community Clinic

    Call Center Patient Service Representative

    3 weeks ago

    Imperial Beach Community Clinic San Diego, United States

    : · **Call Center Patient Services Representative** · **$ $19.00 per hour** · Imperial Beach Community Clinic will promote a healthy community by providing quality health care and resources, with a focus on the underserved. Our mission has been to provide high-quality medical car ...

  • Thunderbolt

    Salesperson/Customer Advisor

    3 days ago

    Thunderbolt San Diego, United States

    For our HIT markets in San Diego, California · Here you start fresh: · Whether it's sausage, meat, cheese or fish - you present our goods in all their variety and freshness. In other words: Your product presentation is something to see and taste. · You inspire in customer con ...

  • Werfen

    Staff Regulatory Specialist

    1 week ago

    Werfen San Diego, United States

    **Job Overview**: · - Post Date · - May 23, 2024 · - Number · - ICIMS · - Job Function · - QA&RA · - Location · - San Diego - AID Old Grove Road San Diego, California United States · - Country · - United States · - Shift · - 1st · **About the Position**: · **Overview**: · **Werf ...

  • PCI Pharma Services

    QA Specialist

    2 days ago

    PCI Pharma Services San Diego, United States

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. · We are PCI. · Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pi ...

  • CorDx

    Regulatory Specialist

    1 week ago

    CorDx San Diego, United States

    **Who is CorDx?** · CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care med ...

  • Zempleo Inc

    Environmental Health

    1 week ago

    Zempleo Inc San Diego, United States

    **OVERVIEW**: · Our client, a US Fortune 250 company and a global medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an accomplished **Environmental Health & Safety Specialist.** · **JOB #**:JP ** · **JOB TITLE ...

  • Insulet Corporation

    Receptionist (On-site)

    1 week ago

    Insulet Corporation San Diego, United States

    Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative ...

  • Guild Mortgage Company LLC

    Loss Mitigation Specialist, Claims

    1 week ago

    Guild Mortgage Company LLC San Diego, United States

    **Guild Mortgage Company**, closing loans and opening doors since 1960. As a mortgage banking firm we are dedicated to serving the home owner/buyer. Our goal is to provide affordable home financing for our customers, utilizing the best terms available while providing a level of p ...

  • American Metal Filter Company

    Online Fulfillment- Order Picker/puller

    3 weeks ago

    American Metal Filter Company Chula Vista, United States

    American Metal Filter Company is a metal mesh air filter manufacturer. · As an Online Fulfillment Specialist, you play a key role in our ability to process online customer orders smoothly and efficiently. Be a part of our team that gets orders ready for our customers by selecting ...

  • City of Vista, CA

    Office Specialist I/ii

    1 week ago

    City of Vista, CA Vista, United States

    **Position**: · The **Office Specialist** classification is an entry-level position into the clerical/administrative series. Office Specialists perform basic, routine clerical work requiring knowledge of department office procedures including a high volume of telephone inquiries. ...

  • Saviance

    USA - SCM specialist

    2 weeks ago

    Saviance San Diego, United States

    Job Title: The Shipping and Receiving SpecialistPay Rates: *** - ***Location: 100% onsite John Jay Hopkins Dr, San Diego, CA 92121Position 1: 12 AM - 10:30 AM Monday-ThursdayPosition 2: 12 AM - 10:30 AM Thursday - SundayPosition 3: 12 AM - 10:30 AM Thursday - SundayJob descriptio ...

  • Saviance

    USA - SCM specialist

    3 weeks ago

    Saviance San Diego, United States

    Job Title: The Shipping and Receiving Specialist · Pay Rates: *** - *** · Location: 100% onsite John Jay Hopkins Dr, San Diego, CA 92121 · Position 1: 12 AM - 10:30 AM Monday-Thursday · Position 2: 12 AM - 10:30 AM Thursday - Sunday · Position 3: 12 AM - 10:30 AM Thursday - Sunda ...

  • VetPride Services, Inc.

    inventory management specialist iv

    3 weeks ago

    VetPride Services, Inc. San Diego, United States

    Inventory Management Specialist IV will help ensure sufficient inventory levels while reducing losses and inefficiencies. An Inventory Management Specialist IV (IMS IV) will perform the below duties in accordance with ASRC Federal ISO certified processes under direct guidance ASR ...

  • Cypress HCM

    Regulatory Affairs Specialist

    3 weeks ago

    Cypress HCM San Diego, United States

    Regulatory Affairs Specialist · The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clini ...