1 regulatory affairs us biologicals labeling specialist Job in de soto, ks
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Regulatory Affairs US Biologicals labeling specialist
$71k-94k (estimate)
Full Time
3 Weeks Ago
SPECTRAFORCE is Hiring a Regulatory Affairs US Biologicals labeling specialist Near De Soto, KS
DeSoto, KS 66018
14 months
QualificationsMinimum Education: Associate degree.
Preferred Education: Bachelor/Master's degree in Life Science.
Required Experience And Skills
Personality
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
14 months
QualificationsMinimum Education: Associate degree.
Preferred Education: Bachelor/Master's degree in Life Science.
Required Experience And Skills
- With Associate, minimum 3-5 years of relevant experience within pharmaceutical labeling experience.
- With Bachelor's, minimum 0-3 years of relevant experience within pharmaceutical labeling experience.
- With Master's minimum 0-2 year of relevant experience within pharmaceutical labeling experience.
- Require someone with scientific background or familiarity with medical terminology.
- Require someone with excellent proofreading skills.
- Proficient in standard computer programs such as Microsoft Office, Excel, Word, Outlook,SharePoint, ADOBE.
Personality
- Attention to details.
- Team Player.
- Able to follow directions.
- Can work independently once the trainings are complete.
- Able to make sure that regulations are met.
- Excellent communication and written skills.
- Open minded.
- Prepare new/revised label packaging for regulatory submissions to the USDA and maintain regulatory documents to ensure site compliance.
- Support regulatory filing submissions with the USDA for both domestic and international product packaging.
- Independently work with internal stakeholders, regulated packaging processes and system workflows to revise or draft new packaging for vaccine biologicals for both US (domestic) and international markets.
- Ensure prompt availability of labels and artworks and liaises with departments such as Marketing, Pharmacovigilance and Technical Services to ensure compliance with established regulations.
- Training with the USDA regulations on packaging, ARTIS computer system and internal processes and workflows for packaging submissions and filing maintenance.
- Training Type: Corporate Development - Coaching
- Regulatory labeling content review as per FDA guideline.
- Quality check of labeling content errors.
- Label artwork, label design review.
- Support the preparation of labeling documents, coordinating labeling document submissions to regulatory bodies.
- Looking for someone with labeling expertise in the pharmaceutical industry, vaccines manufacturing or GMP.
- Very intensive label-oriented job
- Need someone to hit the ground running.
- Label review and submission of labeling documents and artwork
- Label artwork, label design review.
- Quality check for label content and formatting as per FDA guidelines.
- Support the team with the review, revising labeling.
- Attention to details.
- Will prepare the label content following SOP’s and FDA regulations. About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
Job Summary
JOB TYPE
Full Time
SALARY
$71k-94k (estimate)
POST DATE
06/03/2024
EXPIRATION DATE
07/19/2024
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