Investigator

About the role

The Investigator is responsible for leading, conducting, and documenting investigations related to non-conformances and/or complaints within a GMP Pharmaceutical packaging organization. This role utilizes root cause analysis tools, critical thinking, and interviewing techniques to determine root and contributing causal factors. The Investigator will recommend corrective and preventive actions (CAPA) and may lead their implementation through collaboration and teamwork. The position works closely with internal and external stakeholders, focusing on data generation, process evaluation, and performance metrics for customer communication and continuous improvement.

Must possess a working knowledge of FDA regulations pertaining to Pharmaceutical/Packaging Operations and a high level of detail and accuracy. The scope includes Allentown, Macungie, and/or Conshohocken. Decisions related to customer interface, investigation conclusions, and product impact assessments may expose the company to significant risk or economic loss.

Responsibilities

• Identifies issues and independently assesses the need for non-conformance, formulating recommended containment actions with operational leadership.
• Conducts investigations to identify robust root causes using root cause analysis tools across various non-conformance and/or complaint types.
• Independently leads and/or facilitates floor gembas, cross-functional meetings, and operator interviews related to investigations.
• Observes processes on the shop floor, warehouse, and central support functions (e.g., incoming inspection, sales, customer service, project management, validation, and engineering) to ensure factual and detailed investigations.
• Authors investigation reports in the designated QMS using strong organizational and technical writing skills with attention to detail.
• Drives collaboration using strong interpersonal communication skills.
• Leads effective cross-functional root cause analysis, CAPA, and continuous improvement planning and execution with minimal supervision.
• Owns data collection and performance metrics for the investigation process and CAPA effectiveness, facilitating knowledge sharing across the organization.
• Initiates, writes, reviews, and assesses change controls and revises SOPs and Work Instructions as needed for action implementation.
• Recommends potential product impact outcomes using critical thinking and provides thorough supporting documentation.
• Thrives in a dynamic environment, multitasks, and independently prioritizes timelines to support packaging schedules, product disposition, and release in alignment with organizational and customer goals.
• Supports customer relationships related to investigation findings, CAPA implementation, and performance metrics.
• Supports customer and regulatory audits by presenting investigation summaries and conclusions clearly and concisely.
• Leads continuous improvement efforts focused on investigation-related processes or reducing organizational risk by closing GMP gaps.
• Completes QMS actions related to change controls, non-conformance, complaints, and CAPAs.
• Proactively identifies and facilitates the resolution of potential risks.
• Flexible to meet the needs of the organization when required.

Requirements

• All employees must be over the age of 18 and will undergo a preemployment drug test and background check.
• Bachelor’s degree preferred with 1–3 years of related experience, or an associate’s degree with 3–5 years of related experience.
• Experience in the packaging or inspection of pharmaceutical products or a related industry is required.
• Experience in design, documentation, operation, maintenance, and/or improvement of biopharma facilities is preferred.
• Outside certification of quality skills and practices (e.g., ASQ, CQIA, CQI, CQT, Lean Six Sigma) is highly desired.

Skills

• Mathematical Skills: Ability to apply moderately complex mathematical operations, including statistical skills.
• Language Skills: Ability to communicate effectively (written and verbally) with internal teams (Quality, Operations, Sales, Customer Service, Project Management, Validation, and Engineering) and external stakeholders (customers and regulatory agencies).
• Written Skills: High level of writing and verbal skills to provide clear, concise, and legible communication in investigation reports, internal/external correspondence, and procedure writing.
• Reasoning Ability: Ability to independently make rational decisions regarding root cause and CAPA, troubleshoot problems, and think critically.
• Computer Skills: Intermediate proficiency in Windows applications, including Microsoft Office Suite and electronic QMS.

Physical Demands

• Regularly required to use hands to finger, handle, or feel, and talk or hear.
• Frequently required to sit.
• Occasionally required to stand, walk, and reach with hands and arms.
• Specific vision abilities required include close vision, distance vision, and ability to adjust focus.

Work Environment

The employee typically works at a desk or periodically on the shop floor. The environment is clean and not normally subject to hazardous conditions.