Regulatory & Documentation Specialist vacancy in Actalent Downers Grove, IL
This Jobsfunter Listing is about Actalent in Downers Grove, IL 2022
About the job
- Actalent* is hiring for a regulatory and documentation specialist for a major personal care company in the Downers Grove, IL area. This role is ideal for someone with 4-5 years of quality assurance experience OR 2-3 years of regulatory affairs experience in the cosmetics or pharmaceutical industries.
- Description:* -Administers and maintains the Company’s Annual Product Review including generating the reports -Supports administering and maintaining the Company’s Documentation Change Control System for compliance documentation -Monitors regulatory activities (via searches of government internet web sites, review of USP supplements, Federal Register publications, and other government communication vehicles) and proactively presents, advises, and executes internal programs associated with these activities -Assists in maintaining product and raw material master file documentation and databases -Administers the adherence to procedural requirements in the development of Master Records -Proficient at reading, reviewing and auditing documents and following procedures -Ability to understand the importance and the elements of a good change control process and understand compliance product lifecycles -Administer and maintain the Company’s Annual Product Review process and reporting generation -Master the understanding of the cGMP requirements associated with the production and Quality lifecycle of an OTC drug -Solid understanding of technical requirements for all quality and regulatory documentation supporting batch production documents and their lifecycle -Ability to understand and interpret product regulatory requirements from FDA OTC monograph, US Pharmacopeia and/or others, local, state, federal and international regulatory agencies -Ability to monitor regulatory activities (via searches of government internet web sites, review of USP supplements, Federal Register publications, and other government communication vehicles) and understand their impact to the Company
- Skills and Qualifications:* 1.
- Bachelor’s degree in Chemistry, Biology, or related scientific discipline with 4-5 years of applicable Quality Assurance environment experience, preferably in the cosmetics/pharmaceutical OTC industry OR 2-3 years of applicable Regulatory Affairs experience in the cosmetics/pharmaceutical OTC industry.*
- Attention to detail and ability to work well under pressure.
- Capable of managing tactical steps to push tasks forward.
- Effective interpersonal skills to interact with others
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Vacancy Type: Contract · Entry level
Job Location: Downers Grove, IL
Application Deadline: N/A