Quality Assurance Associate

Summary:

The QA Associate is responsible for Quality Control/Assurance tasks and processes within Boiron facilities in accordance with Standard Operating Procedures. The QA Associate must be versatile, independent, an effective communicator and must have strong leadership skills.

Responsibilities:

• Development of product and project specification documentation and master batch records;
• Quality Control inspection, documentation, release and organization of the receiving process for finished product specialties and generics in Boiron US facilities and contract warehouses;
• Quality Control inspection and disposition of materials and product used in assembly projects;
• Compliance review of assembly project batch documentation and finished product release;
• Inspect and process product returns;
• Management and periodic inspection of laboratory product retains;
• Facility environmental data monitoring and support investigations as needed;
• QA Documentation retention, filing, and maintenance;
• Participate in internal audits and support external audit activities;
• Support of product quality complaint filing and investigation as requested;
• Initiate and support investigations and proposal of CAPA;
• Conduct training and manage training documentation;
• Short dated product management activities;
• Regulated waste management activities;
• Support regulatory inspections as requested;
• Support with facility qualification activities;
• Support with WERCS data management;
• Development and revision of branch Standard Operating Procedures;
• Maintain open communication, trouble shoot, and propose solutions with teams to promote the quality culture, resolve challenges and avoid conflict;
• Other duties as assigned

Requirements:

• Bachelor’s Degree in Life Science or related field
• 1-2 years of experience in a Quality or Technical field preferred.
• Understanding of cGMP and pharmaceutical regulatory guidelines preferred
• Knowledge of the JD Edwards inventory management system preferred
• Knowledge of Microsoft Office software with ability to use and willingness to improve skills with Outlook, Word and Excel
• Demonstrate meticulous attention to detail in following procedures, preparing written documentation, and completing QA/QC activities
• Work independently in a leadership role and enforce compliance goals and requirements
• Ability to work in a high paced, multi-tasked environment
• Have a strong affinity for team work
• Self-starter that is hard working with demonstrated leadership, interpersonal and communication skill
• Strong organizational skills
• Strong communication skills