QA Specialist Position Available In Broward, Florida

ACTALENT IS HIRING A TEAM OF QUALITY ASSURANCE INVESTIGATORS // LAB SETTING!

Job Description As a Quality Assurance Specialist, you will be responsible for investigating quality control issues related to raw materials, in-process and finished products, and stability samples. You will identify root causes and implement corrective and preventative actions (CAPAs), ensuring timely completion of these investigations. You will review investigation reports for accuracy, analyze the impact of proposed CAPAs, and discuss findings with relevant departments. Additionally, you will present investigation statuses and findings in Daily Lean Manufacturing (DLM) meetings and audit laboratory procedures for compliance. Responsibilities Investigate quality control issues for raw materials, in-process, finished products, and stability samples. Identify root causes and implement corrective and preventative actions (CAPAs). Review investigation reports for accuracy before approval. Analyze the impact of proposed CAPAs and discuss findings with relevant departments. Ensure timely completion of investigations and CAPAs. Present investigation status and findings in Daily Lean Manufacturing (DLM) meetings. Audit laboratory procedures, production systems, and operational processes for compliance. Prepare detailed reports and maintain documentation related to quality investigations. Design and conduct training on quality control procedures and compliance standards. Mentor and coach team members on laboratory techniques and problem-solving. Collaborate with cross-functional teams to maintain quality integrity. Stay updated on industry regulations and incorporate changes into training materials. Initiate change controls for CAPAs, Effectiveness Checks, STPs, SOPs, and Specifications. Ensure compliance with company policies, safety rules, and regulations. Operate according to the Code of Conduct and Business Ethics. Support risk assessment for laboratory and product-related changes. Assist in customer complaint investigations. Conduct training for analysts on QMS trending, CAPA, STPs, and SOPs. Perform data trending for annual product reviews and reports. Perform other relevant duties as assigned. Essential Skills Investigation and analysis skills cGMP / Investigations / HPLC expertise Quality assurance experience CAPA and root cause analysis Knowledge of chemistry and fishbone analysis FDA compliance and instrumentation expertise QMS (Quality Management System) understanding Additional Skills & Qualifications Bachelor’s degree in Science 5 years of QA experience Experience in GMP and FDA environment