Principal Specialist, Quality Operations

Description

Duties & Responsibilities

• Provides Quality Assurance support with 50% of time spent in Operations focused on compliance with USDA, EU regulatory requirements and BIAH procedures, deviation prevention via right first-time manufacture and documentation, periodic assessments to maintain a state of audit readiness, real-time batch record review, 4-eye verification, calculations, sample control and delivery.
• Influences as a technical resource and departmental SME for Quality related questions or topics including Regulatory, Corporate, and Site-specific requirements.
• Performs full investigations of major events with potential product quality impact for complex products manufactured at BIAH to identify the root cause, impact assessment, and CAPA to assess quality requirements for compliance with USDA, EU, FDA, or other GMP regulatory requirements and proposes disposition of the product.
• Investigates large-scale deviations potentially impacting multiple departments such as facility or utility investigations.
• Triages real-time quality impact of events in conjunction with shop-floor employees in support of deviation management.
• Ensures impacted material is appropriately quarantined and management notified.
• Supports Deviation Risk Assessment.
• Performs operations related investigational activities as assigned in TrackWise child Investigation records in support of High-risk deviations / complaints.
• Performs review and approval of CAPAs associated with the focus area.
• Trains employees on Deviation/CAPA.
• Grants system access to employees as appropriate.
• Conducts internal audits of facility, production floor, equipment, and warehouse and provide written reports summarizing findings.
• Builds understanding and responsibility for area(s) of focus.
• Provides QA assessment and approval for Change Controls.
• Leads major projects and implements improvements in manufacturing procedures or processes as they relate to inspection readiness and Right First Time (RFT) compliance.
• Supports Quality Management activities (e.g., metrics, strategic initiatives, Quality Risk Management (QRM) assessments, Change Control assessment, Change Control closure).
• Performs trending and analysis of deviations and works with responsible area owners to identify opportunities for improvement.
• Serves as a deputy to the QA Investigations Leader in the event of personal absence.
• Supports during Regulatory / corporate audits including contributions to strategies to successfully respond to auditor concerns.
• Leads alignment of quality assurance events with functions across different areas within production (Central Services, Cells / Media Production, Active Ingredient Production, Formulation / Filling / Freeze Drying / Capping Production, and Quality Control Testing).

Requirements

• A Bachelor’s degree in a relevant scientific discipline plus 8 years relevant experience

• Master’s degree in a relevant scientific discipline plus 5 years relevant experience

• PhD in a relevant scientific discipline plus 3 years relevant experience is required.
• Must be able to manage and actively drive multiple investigations and projects at varying stages of completion to meet respective due dates.
• Demonstrates and influences understanding of GMPs, root cause analysis, compliance requirements, and regulatory requirements to assess product, procedures, recommended improvements to make quality decisions.
• Demonstrating advanced technical writing skills to provide complete, timely investigation reports.
• Demonstrating logical skills with excellence in written and verbal communication skills.
• Demonstrating advanced theoretical and practical knowledge of regulated processes and technical disciplines such as 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.
• Organizational skills, and ability to manage tasks based on experience leading projects.
• Ability to communicate clearly and professionally, both verbally and in writing.
• Well-developed interpersonal skills, with the ability to establish highly functional relationships with diverse personalities both within and outside the company.
• Solid knowledge of Good Manufacturing Practice and international regulations.
• Ability to independently make sound decisions and manage priorities in alignment with department and site drivers.
• Ability to make and influence decisions with minimal supervision regarding the acceptability of product based on investigation provided.
• Previous experience in a leadership role preferred.
• Attention to detail and commitment to customer service.
• 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.
• NOTE: Relevant BIAH experience may be weighted more significantly.

• Lifting, pushing, and pulling and/or carrying <25 pounds occasionally.
• Constant periods of sitting.
• Frequent standing, walking, or climbing stairs.
• Crouching/squatting, bending/stooping, twisting, above the shoulder or low-level work, fine finger dexterity/ including grasping required occasionally.
• Writing and typing constantly.

• Color vision required.
• May require extended hours at a computer screen.
• Must be able to read electronic documents of all types.

Desired Skills, Experience and Abilities