Labeling Specialist

Found in: Resume Library US A2 - 2 weeks ago

Santa Rosa California, United States Endologix Full time
Overview:
This position is responsible for managing and implementing the processes associated with the creation of new, and revision of existing, labeling content documents throughout the complete product lifecycle. This position partners with the appropriate groups and subject matter experts to drive product labeling development activities. The position is responsible for the accuracy of labeling documents and compliance with regulatory requirements, internal labeling processes and policies and associated change control. The position will be involved with participating in and responding to internal and external labeling audits, as well as activities related to the development and maintenance of applicable labeling procedures, guidelines, and templates.  This position is responsible for partnering with multiple departments to manage and develop product structure and work instruction documents for manufacturing, warehouse and 3rd party distribution to correctly implement labeling on product.  Additionally, this position is responsible for the development and delivery of training to pertinent functional units regarding labeling processes and supporting systems-based tools.

Responsibilities:
Work with the graphics and translations suppliers to create artwork, drawings and associated documentation for labeling.

Ensure that labeling artwork and proofs are accurate and meet all medical, legal and Global regulatory requirements.

Ensure regulatory compliance, accuracy, timely completion and version control of all new and revised labeling.

Develop/update product structure and work instruction documents to ensure labeling is correctly implemented into product.

Perform continuous coordination, monitoring and expediting of labeling changes to meet established deadlines for regulatory submission and production, as well as product launches.

Structures ancillary teams such that all appropriate functions are present as needed during the label development and approval process.

Serves as primary communication hub for team information regarding labeling. Develops and provides guidance for labeling as needed, such as use of pre-printed or CGL labels, translations, specific country or region label requirements and label production.

Works with the initiator and/or the project team (Operations, Marketing, Regulatory Affairs, Quality, R&D and Clinical Affairs) to identify potential labeling issues and to define and implement solutions.

Work with procurement and labeling print vendors to ensure correct labeling components are produced.

Manage barcode processes and systems as related to product labeling.

Working knowledge of computer generated labeling systems/output.

Key Performance Indicators: Artwork/Labeling must be 100% accurate and meet submission and production schedules.

Manages special project assignments to support Labeling as needed. This can include, but is not limited to, training, process improvements and procedure development.

Qualifications:
Education:

Bachelor’s degree from an accredited higher learning institution or higher in scientific field or equivalent in number of years of experience.

Experience:

5+ years combined experience in the pharmaceutical, biologics or medical device industries with a minimum of 3 + years of product labeling experience.

Must have a thorough understanding of Global product labeling regulations and regulatory processes (medical/safety/regulatory/corporate).

Proven ability to lead and work effectively in cross-functional teams to develop consensus on disparate issues, and have a general understanding of labeling operations relevant to product packaging/manufacturing processes.

Strong problem solving skills.

Experience in cGMP/GDP/GCP environments, packaging, and FDA regulated industries strongly preferred.

Proficiency in Microsoft Word, Excel, and Adobe Acrobat required.

Demonstrated expertise in managing the labeling content business process, including change control; knowledge of labeling content across all company products.

Compensation: $77,000 to $121,000 annual salary depending on experience.  

  • Product Development Specialist

    Found in: Resume Library US A2 - 2 weeks ago

    Fresno, California, United States TeamBuilders Employment Full time

    Job Description TeamBuilders is hiring for a Product Development Specialist to join a Food Processing company in the Fresno, CA area.   The Product Development Specialist will be responsible for developing recipes of food products with a variety of ingredients while ensuring the final product is flavorful and packaged appropriately for the end...

  • Regulatory Affairs Specialist

    Found in: Appcast Linkedin GBL C2 - 3 weeks ago

    Santa Clara, United States GForce Life Sciences Full time

    Regulatory Affairs Specialist II – Santa Clara, CA Must be able to work on a W2Job Summary We're looking for a Regulatory Specialist with 2-5 years of experience in the medical device industry. Your responsibilities include maintaining the quality system, supporting manufacturing operations, and providing regulatory guidance. Experience with international...

  • Regulatory Affairs Specialist

    2 weeks ago

    Santa Clara, United States GForce Life Sciences Full time

    Regulatory Affairs Specialist II Santa Clara, CA Must be able to work on a W2 Job Summary We're looking for a Regulatory Specialist with 2-5 years of experience in the medical device industry. Your responsibilities include maintaining the quality system, supporting manufacturing operations, and providing regulatory guidance. Experience with international...

  • Regulatory Affairs Specialist

    Found in: Appcast US C2 - 3 weeks ago

    Santa Clara, United States GForce Life Sciences Full time

    Regulatory Affairs Specialist II – Santa Clara, CA Must be able to work on a W2Job Summary We're looking for a Regulatory Specialist with 2-5 years of experience in the medical device industry. Your responsibilities include maintaining the quality system, supporting manufacturing operations, and providing regulatory guidance. Experience with international...

  • Sr. Regulatory Affairs Specialist

    Found in: Resume Library US A2 - 2 weeks ago

    Orange County, California, United States BioTalent Full time

    POSITION SUMMARY The primary responsibility of the Senior Regulatory Affairs Specialist is to manage and perform regulatory submissions for local and worldwide regulatory agencies. The Sr. RAS is also responsible for ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product...

  • Regulatory Affairs Specialist

    7 days ago

    Santa Clara, United States GForce Life Sciences Full time

    Regulatory Affairs Specialist Santa Clara, CA Must be able to work on a W2 Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry. Key Responsibilities:...

  • Regulatory Affairs Specialist

    7 days ago

    Santa Clara, United States GForce Life Sciences Full time

    Regulatory Affairs Specialist– Santa Clara, CA Must be able to work on a W2 Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry.Key...

  • Regulatory Affairs Specialist

    Found in: Appcast Linkedin GBL C2 - 3 weeks ago

    Santa Clara, United States GForce Life Sciences Full time

    Regulatory Affairs Specialist– Santa Clara, CA Must be able to work on a W2 Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry.Key...

  • Desktop Support Specialist

    13 hours ago

    Santa Ana, United States CareerBuilder Full time

    + Location: United States, California, Santa Ana + Creation date: 2021-05-26 + Location: United States, California, Santa Ana + Creation date: 2021-05-26 + Location: United States, California, Santa Ana + Creation date: 2021-05-27 + Location: United States, Colorado + Creation date: 2021-06-02 + Location: United States, Utah + Creation date: 2021-06-02 +...

  • Desktop Support Specialist

    2 weeks ago

    Santa Ana, United States CareerBuilder Full time

    + Location: United States, California, Santa Ana + Creation date: 2021-05-26 + Location: United States, California, Santa Ana + Creation date: 2021-05-26 + Location: United States, California, Santa Ana + Creation date: 2021-05-27 + Location: United States, Colorado + Creation date: 2021-06-02 + Location: United States, Utah + Creation date: 2021-06-02 +...

  • Desktop Support Specialist

    2 weeks ago

    Santa Ana, United States JMAC Lending Full time

    + Code: 2 + Location: United States, California, Santa Ana + Creation date: 2021-07-01 + Location: United States, California, Santa Ana + Creation date: 2021-05-26 + Code: 1 + Location: United States, California, Santa Ana + Creation date: 2021-07-01 + Location: United States, California, Santa Ana + Creation date: 2021-06-29 + Location: United States,...

  • Regulatory Affairs Specialist

    1 week ago

    Santa Clara, United States CareerBuilder Full time

    Regulatory Affairs Project Lead Santa Clara, CA Must be able to work on a W2 Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and commercial, and affiliate personnel in the medical device industry. Key Responsibilities:...

  • QC Specialist

    Found in: Appcast US C2 - 2 weeks ago

    Santa Ana, United States BioPhase Full time

    BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a QC Specialist to work for an early-stage, Orange County Biotechnical company.Salary Range : $25 - $35/Hour Purpose of PositionSeeking a highly motivated and enthusiastic individual to join our dynamic biotech...

  • QC Specialist

    Found in: Appcast Linkedin GBL C2 - 3 weeks ago

    Santa Ana, United States BioPhase Full time

    BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a QC Specialist to work for an early-stage, Orange County Biotechnical company.Salary Range : $25 - $35/Hour Purpose of PositionSeeking a highly motivated and enthusiastic individual to join our dynamic biotech...

  • Environmental Specialist

    Found in: Resume Library US A2 - 5 days ago

    San Diego, California, United States Veolia Full time

    Job Description Targeted Hourly Pay: minimum of $24.00 to a maximum of $26.00 BENEFITS  Veolia's comprehensive benefits package includes paid time off policies, as well as health, dental and vision insurance. In addition, employees are also entitled to participate in an employer sponsored 401(k) plan, to save for retirement.  Pay and benefits for...

  • Product Specialist Coordinator

    Found in: Resume Library US A2 - 3 days ago

    El Segundo, California, United States Saatchi & Saatchi (We Are Saatchi) Full time

    Job Description This position will review all retail advertising materials to ensure product correctness of Toyota vehicles, pricing and equipment depicted. This includes regional advertising, running footage, wheel stands and value labels for all Toyota vehicles. The Coordinator will also manage vehicles for retail shoots working with car prep to ensure...

  • Medical Records Clerk

    2 days ago

    Santa Fe, United States La Familia Medical Center Full time

    Position Function SummaryUnder the direction of the Medical Records Coordinator, the Medical Records & Health Information Technician maintains the confidential patient medical records for release to LFMC providers and external agencies. Receives correspondence for inclusion into the medical record to insure accurate and timely information is available to all...

  • Motion Planning ML Engineer

    Found in: beBee S US - 3 weeks ago

    Costa Mesa, California, United States Anduril Industries Full time

    WHY WE'RE HERE The Vehicle Autonomy (Robotics) team at Anduril develops aerial and ground-based robotic systems. The team is responsible for taking products like Ghost, Anvil, and our Sentry Tower from paper sketches to operational systems. We work in close coordination with specialist teams like Perception, Autonomy, and Manufacturing to solve some of the...

  • Materials Manager

    Found in: Resume Library US A2 - 2 weeks ago

    San Francisco, California, United States SCA Health Full time

    Overview: Today, SCA Health has grown to 11,000 teammates who care for 1 million patients each year and support physician specialists holistically in many aspects of patient care. Together, our teammates create value in specialty care by aligning physicians, health plans and health systems around a common goal: delivering on the quadruple aim of high-quality...

  • Executive Director

    Found in: Appcast Linkedin GBL C2 - 3 weeks ago

    Santa Cruz, United States MHCAN Full time

     JOB DESCRIPTION Position Title:           Peer Run Drop In Executive Director      Reports to:                 MHCAN Board of Directors         If you are interested in this position, please send your completed application, a resume and cover letter explaining how you identify as a mental health peer to...