Investigator

Summary The Investigator is responsible to lead, conduct and document investigations relating to non‑conformances and/or complaints within a GMP Pharmaceutical packaging organization. The Investigator will utilize root cause analysis tools, critical thinking and interviewing techniques to determine the root and contributing causal factors of non‑conformances/complaints. The Investigator will offer recommendations to correct and/or prevent recurrence through CAPA design from the root cause conclusion of the investigation. The Investigator will lead, as necessary, the implementation of associated corrective and preventative actions through collaboration, teamwork and influence. The position will work closely and in collaboration with internal and occasionally external stakeholders. The Investigator also has responsibilities for data generation, process evaluation and performance metrics for the purposes of customer communication and driving continuous improvement. Must possess a working knowledge of FDA regulations pertaining to Pharmaceutical /Pharmaceutical Packaging Operations and a high level of detail and accuracy. The scope of the position includes Allentown, Macungie and/or Conshohocken. The impact of decisions relating to customer interface, investigation conclusions, and documentation supporting recommendations for product impact assessments could expose the company to significant risk or economic loss. Essential Duties and Responsibilities Identifies issues and can independently assess the need for non‑conformance and formulate recommended containment actions in conjunction with operational leadership. Conduct investigations that identify robust root cause by effectively applying root cause analysis tools across a variety of non‑conformance and/or complaint types. Independently lead and/or facilitate floor gembas, cross functional meetings, and operator interviews related to investigations. Observe processes on shop floor, warehouse, and central support functions (incoming inspection, sales, customer service, project management, validation, and engineering) to ensure investigation is factual and detailed. Author investigation reports in designated QMS utilizing strong organizational and technical writing skills with demonstrated attention to detail. Drives collaboration utilizing strong interpersonal communication skills. Lead effective cross‑functional root cause analysis and CAPA and Continuous Improvement planning and execution with minimal supervision. Owns data collection and performance metrics relative to the investigation process and CAPA effectiveness and facilitates sharing of investigational findings and risk knowledge through the organization. Initiates, writes, reviews and assesses change controls and revises SOPs and Work Instructions as needed for action implementation. Utilizes knowledge, experience, and critical thinking skills to recommend potential product impact outcomes and provides thorough supporting documentation and justification for those outcomes. Ability to thrive in a dynamic environment, multi‑task, and independently prioritize and manage timelines to support packaging schedule, product disposition and release in alignment with organizational and customer goals. Supports customer relationships related to investigation findings, CAPA implementation and performance metrics and process improvements. Supports customer and regulatory audits as needed by presenting investigation summaries and conclusions in a thoughtful, clear and concise manner. Lead continuous improvement efforts focused on investigation related processes or the reduction and/or elimination of organizational risk by closing GMP gaps. Complete QMS actions related to change controls, non‑conformance, complaints and CAPAs. Proactively identify and facilitate resolution of potential risks. Must be flexible to meet the needs of the organization when required. Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Preferred / Required Education and Experience Bachelor’s degree is preferred with one to three years related experience or associate’s degree with three to five years of related experience. Experience in the packaging or inspection of pharmaceutical products or 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 (i.e. ASQ, CQIA, CQI, CQT, Lean Six Sigma etc.) is highly desired. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel and talk or hear. The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus. Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor. The working environment is clean and not normally subject to hazardous environment or conditions. Disclaimer This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice. #J-18808-Ljbffr