QA Compliance Investigator

Job Overview:

Responsibilities:

• Support compliance activities for site Quality Compliance in accordance with standards, procedures, and cGMPs as applicable. 
• Collaborate with site personnel to provide guidance and determine the resolution for manufacturing issues.
• Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls, and complaints.
• Support regulatory inspections and audits by ensuring inspection readiness within the facility.
• Perform internal housekeeping audits.
• Perform analysis on quality indicating data and identifying trends, escalating to supervisor in a concise, well-organized, and timely manner.
• Provide oversight for trending of quality compliance metrics.
• Work in a collaborative team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support, Maintenance, Supply Chain, and Planning.
• Document investigation reports and findings in designated Quality systems.
• Ensure required management and Quality approvals on final investigations while satisfying established due dates.
• Facilitate corrective and preventive action agreements with stakeholders.
• Facilitate internal sharing of investigational findings and risk knowledge.
• Contribute to metrics related to the investigation process and CAPA effectiveness.
• Present investigations during internal and external audits.
• Collaborate cross-functionally to ensure robust investigation conclusions, effective communication, and sharing of learnings.
• Perform other duties as assigned.

Qualifications: 

• Bachelor’s degree in Science, Engineering, Biotechnology, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
• A minimum of 5 years of relevant work experience is required.
• Experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy preferred.
• cGMP manufacturing knowledge, preferred.
• Demonstrate basic math skills.
• Demonstrate familiarity with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities.
• Demonstrates the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.
• Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
• Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
• Must be able to comprehend and follow all applicable SOPs.
• Demonstrate knowledge / Experience with electronic Quality Management Systems such as MasterControl / TrackWise.
• Demonstrate knowledge of current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
• Demonstrate good understanding of cGMPs, industry, and regulatory standards and guidelines.
• Demonstrate familiarity with Microsoft programs like Word, Excel, Teams, and Outlook.
• Demonstrate the ability to portray the appropriate level of integrity and professionalism.
• Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
• Demonstrate the ability to complete tasks accurately according to established and shifting timelines.
• Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
• Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
• Results-oriented and efficient.
• Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
• Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
• Demonstrate the ability to work well in a cross-functional team environment.
• Must communicate fluently in English and have legible handwriting.

Physical Demands: 

• Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
• Ability to lift up to 40 pounds on occasion.
• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).