Principal Specialist, Investigation

Duties & Responsibilities

• Performs the investigation of deviations for somewhat complex products manufactured at BIAH to identify the root cause, impact assessment, and CAPA to assess quality requirements to comply with USDA, EU, FDA, or other GMP regulatory requirements and proposes disposition of the product.
• May be assigned to or assist with investigational reports not associated local deviations such as TPMQ, complaint, or other facility investigations.
• Participates on investigation related project teams to evaluate events, which are investigated.
• Completes maintenance of systems associated with the investigation function.
• Produces the technical investigation report detailing the findings and assessment of the investigation under some direct supervision.
• Investigation reports and impact assessments are complete and compliant with regulations.
• Serves lead as a QA representative and SME on assigned internal and external project teams (change controls, process improvements, technology transfer, training, business process excellence, electronic system deployment) as a technical/compliance resource to solve quality related issues.
• Communicate new requirements/perform training with QA Investigation team to assure all time-lines are met resulting in successful project completion and new product launches.
• Afford assistance with internal, regulatory or corporate audits to ensure compliance with domestic and international regulations, quality requirements and guidance documents.
• Afford assistance with audit responses and completion of assigned CAPAs by target due dates. Included is the responsibility for making sure QA Investigation areas are 'inspection ready' at all times.
• Influences as a technical resource and departmental SME for quality related questions or topics including Regulatory, Corporate, and Site Specific requirements.
• Performs all company business in accordance with all regulations (e.g. GMP, USDA, FDA, EU etc.) and Company policy and procedures.
• Demonstrated high ethical and professional standards with all business contacts in order to maintain BIAH's excellent reputation in the community.
• When violations are noted or observed, they are immediately reported to management.
• Serves as a deputy to the QA Investigations Leader in the event of his/her absence.

Qualifications

• A BS degree from an accredited institution in a relevant scientific discipline plus eight (8) years relevant experience OR MS degree from an accredited institution in a relevant scientific discipline plus five (5) years relevant experience OR PhD from an accredited institution in a relevant scientific discipline plus three (3) years relevant experience is required.
• NOTE: Relevant BIVI experience may be weighted more significantly.
• Influencing technical writing skills to provide complete, timely investigation reports.
• Demonstrating logical skills with excellence in written and verbal communication skills.
• Influencing theoretical and practical knowledge of regulated processes and technical disciplines such as root cause analysis, sterilization, aseptic processing, QC testing, quality and compliance, production excellence, and/or maintenance services.
• Able to select, develop, and assess the appropriateness of regulated processes and technical disciplines associated with the manufacture, testing, and verification of products manufactured by BIAH.
• Demonstrating ability to lead and influence large projects and teams.
• Able to make and influence decisions with minimal supervision regarding the acceptability of product based on investigation provided.
• Technically self-sufficient and proficient in the performance of investigations including root cause analysis, impact assessment, CAPA development, and effectiveness of CAPA plans.
• Excellent attention to detail.
• Requires ability to utilize computer programs such as Microsoft suite, SAP, IDEA for CON, Learning One Source, TrackWise and other relevant electronic applications.