Labeling Specification Specialist Jobs

Conduct high level proof-reading capabilities.

Maintain current knowledge of U.S. FDA submission standards.

Normal office situation or remote.

Key responsibilities for this role include:

The minimum qualifications for this role are:

Access – Providing high quality trusted medicines regardless of geography or circumstance;

Utilizing Salesforce.com as a customer relationship, project tracking and time management tool

Recommending door and hardware solutions to meet the design requirements for security, aesthetics, sustainability, and accessibility.

Working in tandem with our Architectural Consultants to foster a positive customer experience and deliver on time project deliverables.

Designing electrified access control product and software systems for door openings.

Assisting with project submittal reviews and substitution approval processes to ensure specifications are held in the bid process.

What you will being doing

Provide additional support for certification programs

Education: Bachelor’s degree in Food Science, Chemistry, Biology, or related fields

Experience: Minimum 1 year of responsibility in food or supplement industry and/or supplemental regulatory role

Knowledge of regulatory affairs, quality documentation, and business processes (stage gates)

Excellent communication skills, both written and oral

Experience with ESHA Genesis is preferred but not required

The responsibilities of this position may include, but are not limited to, the following:

Master and Executed Batch Record review and resolution of comments/issues

Archiving of batch documents in electronic document system

Track data for the purpose of metrics generation

Evaluations of Investigations/ OOS/ Change Controls to support Disposition Status

Disposition Decision and status change in Oracle

Experience in the ag-chem or other chemical industry helpful to understand the critical nature of labeling accuracy and requirements.

This position does not require creativity design experience. It requires more attention to details and organizational skills.

Attention to detail skills a must!

Ability to learn new technology applications. Adobe Creative Suite (InDesign, Illustrator) knowledge a plus.

Clerical and critical thinking skills.

Creates California Printer’s Proofs for Regulatory Specialists submissions.

Strong computer skills and technical troubleshooting abilities

Work remotely from the comfort of your own home

Answer complex inbound account inquiries and provide advanced knowledge of Visa, Retail, Debit, Loyalty Program, and Gift Card products

1+ years of customer service experience

Excellent communication skills, both verbal and written

Ability to handle a high volume of calls with accuracy and deliver excellent customer experiences

· “From -> To” redline creatio

The ideal support should cover these bases:-

· Onsite availability would be a nice to have for better collaboration when needed

The CAD/drawing work itself includes:-

· Conversion of critical dimension callouts to a new convention

Functional/Technical Knowledge, Skills and Abilities

Commitment to learn and stay abreast of global medical devices regulatory requirements.

Minimum 7 years' experience in related work experience

Experience with regulatory documentation is preferred

Excellent communication and interpersonal skills

Serve as company-wide labeling SME working with various workstreams to maintain compliant labeling needs.

US military experience will be considered towards industry experience requirements.

Manages external requests for country specific labeling information (e.g. medical content, pharmaceutical properties) from various source or reference documents.

Maintains an understanding of regulatory labeling requirements of assigned region or countries.

Must possess an excellent command of language (English) and professional knowledge of medical terms,

Experience working on multi-disciplinary teams and projects

Good knowledge of rigorous pharmaceutical and/or scientific documentation practices and change control processes (e.g. revision control)

2+ years of labeling experience within medical device/pharma/food industry

Ensures that labeling art film and plate proofs meet all medical legal and regulatory requirements.

***Compensation within this range will be commensurate with level of experience***

Monitors changes in labeling regulations in the US and/or abroad.

Reviews promotional and commercial communication material and ensures that it is supported by the data and consistent with the application.

Monitor evaluate and recommend improvements to labeling processes quality systems tools and/or policies.