Synectics
Labeling Compliance Coordinator
Synectics, Oldsmar, Florida, United States, 34677
Responsibilities:
The Labeling Compliance Coordinator will support the labeling specialist by performing administrative tasks, including assigning GTINs, submitting to Compendia, proofreading artwork, managing control documentation, performing data lookups, and assisting with peer and visual reviews.This position is essential for ensuring the company meets deadlines and maintains high accuracy in labeling processes.The coordinator will work closely with the Regulatory Labeling Compliance Specialist to maintain schedules and aid in peer reviews for labeling documentation.This role offers a dynamic opportunity to learn and grow within the OTC labeling field.Perform GTIN assignments and submit documentation to CompendiaProof and peer-review labeling documentation for accuracy. Review all product labeling components in a timely manner, for accuracy and ensuring full compliance with industry regulations, customer requirements, and style guidesAssist the Regulatory Affairs Label Compliance in other administrative tasks related to labeling processesProvide active support to the Product Development, Customer Service, QA, and related departmentsMaintain an accurate and current knowledge of pertinent industry regulations: Food and Dietary Supplement labeling regulations (CFR/DSHEA/FTC)Have a good understanding of current good manufacturing practices (cGMP) regulationsMaintain a positive, collaborative approach when working with cross-functional teams.Position Qualifications
1+ years' experience in a manufacturing environment. (Regulatory Affairs, Quality, or R&D experience preferred)Experience with GTIN data and Compendia submissions (willing to train)Strong computer skills including Microsoft Word and Excel. Adobe Creative Suite or any Document Control SystemStrong attention to detail, with the ability to proofread and compare labeling against specifications.Familiarity with QA documentation and labeling regulations is a plus.Excellent organizational skills with the ability to manage multiple tasks and deadlines.Ability to perform mathematical calculations for verifying product potencies.Strong communication skills, both verbal and writtenAbility to work closely with a team and take direction.A positive attitude and a willingness to learn1+ years of work experience with Microsoft Office1+ years of Pharmaceutical Manufacturing experience
The Labeling Compliance Coordinator will support the labeling specialist by performing administrative tasks, including assigning GTINs, submitting to Compendia, proofreading artwork, managing control documentation, performing data lookups, and assisting with peer and visual reviews.This position is essential for ensuring the company meets deadlines and maintains high accuracy in labeling processes.The coordinator will work closely with the Regulatory Labeling Compliance Specialist to maintain schedules and aid in peer reviews for labeling documentation.This role offers a dynamic opportunity to learn and grow within the OTC labeling field.Perform GTIN assignments and submit documentation to CompendiaProof and peer-review labeling documentation for accuracy. Review all product labeling components in a timely manner, for accuracy and ensuring full compliance with industry regulations, customer requirements, and style guidesAssist the Regulatory Affairs Label Compliance in other administrative tasks related to labeling processesProvide active support to the Product Development, Customer Service, QA, and related departmentsMaintain an accurate and current knowledge of pertinent industry regulations: Food and Dietary Supplement labeling regulations (CFR/DSHEA/FTC)Have a good understanding of current good manufacturing practices (cGMP) regulationsMaintain a positive, collaborative approach when working with cross-functional teams.Position Qualifications
1+ years' experience in a manufacturing environment. (Regulatory Affairs, Quality, or R&D experience preferred)Experience with GTIN data and Compendia submissions (willing to train)Strong computer skills including Microsoft Word and Excel. Adobe Creative Suite or any Document Control SystemStrong attention to detail, with the ability to proofread and compare labeling against specifications.Familiarity with QA documentation and labeling regulations is a plus.Excellent organizational skills with the ability to manage multiple tasks and deadlines.Ability to perform mathematical calculations for verifying product potencies.Strong communication skills, both verbal and writtenAbility to work closely with a team and take direction.A positive attitude and a willingness to learn1+ years of work experience with Microsoft Office1+ years of Pharmaceutical Manufacturing experience