Documentation Coordinator – Technical Writer Position Available In Broward, Florida

Documentation Coordinator – Technical Writer 3.7 3.7 out of 5 stars Tamarac, FL 33321 Job Responsibilities Carries out responsibilities in accordance with Aveva’s policies, procedures, and safety rules in accordance with local, state and federal laws. Interfaces with R D, Production, Analytical Development, Quality Assurance, Engineering and Regulatory departments to carry out project objectives. Prepare final reports and assures they are approved through proper channels. Performs data review for the release and stability testing for raw materials, components, standards, intermediate/finished products. Prepares verification protocols for in-house/compendia test methods Reviews technology transfer protocols and assists in evaluations Reviews laboratory work and approves data packages as designated by the Supervisor Maintains a heightened proficiency with data acquisition systems (Empower, LIMS) Review audit trails in Empower and other software. Writes and reviews STPs, SOPs, Specifications and technical reports Works as a member of a team to achieve all outcomes Performs all work in support of our

Values:

Innovate, Evolve and Excel. Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements Prepare and review stability protocols and reports. Prepare excel sheet validations and custom field calculations. All other relevant duties as assigned. Education and/or Experience Bachelor’s degree (B. S.) in chemistry or related field. A minimum of 5-7 years of lab experience in a cGMP regulated manufacturing environment is required. Knowledge, Skills and Abilities Analyzing and troubleshooting problems, identifying solutions and recommending and implementing methods, procedures, systems and/or techniques for resolution. Experience in project management is a plus Superior organizational, interpersonal communication skills Ability to manage time effectively Ability to work independently and manage multiple priorities in a fast-paced and changing environment Good command of the English language, both written and verbal Knowledge of Current Good Manufacturing Practices, (cGMPs), Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and other regulatory requirements. Hands-on experience on HPLCs, GCs, Balances, FTIR, Karl Fisher, UV-Vis, Strong knowledge of data handling chromatography system (i.e., Empower 3, etc). Knowledge of the Stability Programs and current regulations.