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Group: JOBS 2.0: Job Search Career Networking Staffing. Post Resume -Get Paid by Employers at Resumark .com Subject: Robert Ciociola posted a job: "Looking for a Shipping Qualification Progam Analyst - Stability/Lab in Fort Washington, PA Shipping Qualification Progam Analyst - Stability/Lab-Fort Washington,PA Contract Position-24 months Send resumes to: bciociola@covexllc.com Overview of responsibilities and assignments/ deliverables to include: The purpose of this role is to support the evaluation of stability data, used to establish shipping qualification statements, by using the appropriate departmental SOPS and Regulatory Guidance’s for Companies Consumer Healthcare. To perform this role the candidate must work cross-functionally and collaborate with QA, R&D, External Manufacturing, Global Transportation, and Shipping Logistics Company. In addition to this, the individual will play a critical role in providing thorough review, assessment of data previously generated to author the of Shipping Qualification Statements. The individual will need an understanding of the temperature ranges that the products may encounter throughout the supply chain. The candidate will play a critical role in identifying products that may need additional stability information. This individual will be responsible for maintaining critical project timelines. Initiatives/tasks could include but are not limited to the following: (1) Participate in regular cross functional team meetings to ensure that key milestones are met, (2) Identify and consolidate existing, relevant data for integration into the Shipping Qualification Statement. (3) Conducting a gap analysis of stability data by product and SKU and presenting the analysis. (4) Author the Shipping Qualification Statement to include excursions in temperatures and durations for the product/package configuration. (5) Other tasks as assigned. This individual will be responsible to ensure quality and compliance in all actions by attending timely GMP training designated for this role. Other training may be required on an ongoing basis. Education: A minimum of a B.S. Experience/Technical Competencies: 5+ years of experience in the Pharmaceutical industry with Stability experience working with solid dose, liquids, suspensions, and topicals is preferred. Experience in writing technical documentation is required. Previous experience conducting stability testing and evaluating the data is required. Broad knowledge and experience with regulatory requirements including ICH, FDA, SUPAC, and compendia (e.g. USP, EP etc.) is preferred. Experience working in a GMP regulated environment including knowledge of GMP’s GLP’s, SOPs, OOS/OOT investigations and regulatory trends, is required. Effective communication skills with all levels, time management skills and strong computer skills are required. Laboratory experience performing assay, dissolution and physical testing is preferred. Experience with Over the Counter Pharmaceuticals (OTCs) is required. Job Knowledge/Skillsets: Experience working in a cross functional, fast-paced environment is required. A highly motivated individual with strong technical, analytical and interpersonal skills and the abilit... http://bull.hn/l/MZ4A/"

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