Job Description

Job Description

Job Description

Job Overview:

The QA Compliance Investigator has the responsibility of providing quality oversight over the creation, management, and approval of quality investigations. This includes supporting and approving manufacturing investigations, ownership of various department projects, and tracking of quality metrics while ensuring high quality and compliant product supply.

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).

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