Quality Assurance Specialist Position Available In Broward, Florida

Actalent is Hiring a Quality Assurance Specialist! Job Description As a Quality Assurance Specialist, you will investigate quality control issues related to raw materials, in-process, finished products, and stability samples. You will identify root causes and implement corrective and preventative actions (CAPAs), ensuring the accuracy of investigation reports before approval. Additionally, you will analyze the impact of proposed CAPAs, discuss findings with relevant departments, and ensure the timely completion of investigations. Responsibilities Present investigation status and findings in Daily Lean Manufacturing 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 compliance knowledge Experience with Investigations and HPLC Quality assurance expertise CAPA implementation Root cause analysis Strong understanding of chemistry Fishbone analysis FDA compliance knowledge Instrumentation proficiency QMS familiarity Additional Skills & Qualifications Bachelor’s degree in Science 5 years of QA experience Experience in GMP and FDA environment Work Environment This position is based on-site in Tamarac, working Monday to Friday from 8 am to 5 pm in a cleanroom environment. The specialist will have their own office space but will also be required to engage on the floor and communicate with SMEs. Joining a pharmaceutical manufacturer in substantial growth mode, there is a clear career path for growth as the company brings a variety of generic pharmaceuticals to the world.