Investigator and Trainer Position Available In Broward, Florida

Investigator and Trainer 3.7 3.7 out of 5 stars 10200 NW 67th Street, Tamarac, FL 33321

Job Responsibilities:

Conducts thorough investigations into quality control discrepancies and nonconformities for raw material, inprocess, finished product and stability samples. Recognize critical path for investigations leading to timely identification of root cause, corrective & preventative actions (CAPAs). Ensure identification of most probable root cause, corrective action & preventative action for all completed investigations. Review all investigation reports for completeness and accuracy prior to approval by Department Manager. Conduct impact analysis of proposed corrective & preventative actions. Discuss findings with impacted departments and prepare recommendations for Department Managers. Ensure investigations are issued; tasks are appropriately assigned for completion or corrective and preventative actions and are closed in a timely fashion. Participate in Daily Lean Manufacturing meetings (DLM) to present status and findings of investigations to relevant stakeholders. Perform audits of laboratory procedures, production systems, or operational processes to ensure compliance with established guidelines. Prepare detailed reports and maintain accurate documentation related to quality investigations. Design and conduct training focused on quality control procedures, compliance standards, and best practices. Mentor and coach team members on effective laboratory techniques, documentation, and problem-solving approaches. Collaborate with cross-functional teams, including production, research, and quality assurance teams, to maintain quality integrity. Stay current on industry regulations and standards, incorporating updates into training materials and protocols. Initiate change controls for CAPAs, Effectiveness Checks, STPs, SOPs, Specifications. Ensures compliance with all Company policies and procedures including safety rules and regulations. Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements. Performs all work in support of our

Values:

Innovate, Evolve and Excel. Support risk assessment for the existing and future laboratory and product related changes. Support in customer complaint investigations. Conduct training for the analysts (QMS trending, CAPA, STPs and SOPs). Perform data trending for annual product reviews and reports. 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 lab experience in a cGMP regulated manufacturing environment is required. Knowledge, Skills and Abilities Experience in HPLCs, GCs, Balances, FTIR, Karl Fisher, UV-Vis, Strong knowledge of data handling chromatography system (ex. Empower 3, etc). Analyzing and troubleshooting problems, identifying solutions and recommending and implementing methods, procedures, systems and/or techniques for resolution Experience in quality control, laboratory investigation, and training roles. Strong analytical skills with the ability to identify root causes and implement solutions. Excellent communication and interpersonal skills for training and collaborative work. Familiarity with industry standards and compliance regulations (ex.

ISO, GMP, FDA

). Fluency in root cause analysis tools Knowledge in Trackwise or other QMS software 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 Proficiency with Word and Excel