Sr. Specialist, Quality Control

Position Overview

Basic functions & Responsibilities:
Essential function(s) include, but are not limited to: responsibility for daily operation of cells including coordination of testing and data review to meet due dates and coordination of quality notifications; drives continuous improvements, lean activities, kaizens and KATA methodology; performs quality sampling, testing, and release for bulk raw materials, active pharmaceutical ingredients, water, microbiological limits, primary packaging components and finished pharmaceutical products.

• Drives continuous improvement and supports sustainability of implemented changes identified through lean tools such as Kaizens and/or champions new actions as a result of data obtained through lean six‑sigma tools such as KATA methodology.
• Drives deviation reduction through trending and proactive identification of improvement initiatives; mentors others to ensure right‑first‑time performance.
• Leads TierI activities and actively participates in TierII and TierIII when needed.
• Demonstrates subject‑matter expertise for knowledge transfer of laboratory SOPs, product performance and method expertise.
• Provides an environment conducive to the 12 Inclusive Behaviors, actively promotes inclusion and leads by example.
• Leads the management of the investigation program, ensuring on‑time completion of investigations and robust root‑cause and corrective actions are identified.
• Evaluates trends in performance and implements changes to reduce and prevent deviation occurrences.
• Leads the completion of responses and remediation for monthly walk‑through audits; drives proactive actions to ensure laboratory compliance.
• Provides direction and training to laboratory resources with expert knowledge of instrumentation and methodology.
• Monitors equipment availability and minimises laboratory equipment downtime; works cross‑functionally for prioritisation of equipment and off‑site resources when needed.
• Maintains compliance with corporate policies, guidelines and SOPs; mentors others to ensure understanding and adherence to regulatory expectations.
• Ensures optimal daily operation of the laboratory, including level loading of testing workload and remediation of unplanned deviations that impact testing regimes.
• Tests and interprets results for raw materials, active pharmaceutical ingredients, water, microbial limit testing, finished pharmaceutical products and stability samples.
• Manages profit plan/budget activities to ensure efficient laboratory operation and drive improvement opportunities.
• Interprets compendial and internal monographs, NDAs and company quality standards.
• Provides technical and analytical support for cleaning validations, laboratory support requests, equipment validations, method transfers and API Stability Packaging Description (ASPD).
• Has a deep understanding of cGMP, CFR and other agency regulations to assure laboratory compliance; evaluates laboratory SOPs and recommends improvements to maintain compliance; develops or revises laboratory SOPs as required.
• Leads promotion of safety, 5S and other local and corporate initiatives.

Supports quality assurance by ensuring appropriate quality controls and the validity of quality managerial and patient safety activities. Performs corrective and preventive actions to mitigate risk and demonstrates a 360‑degree understanding of the project and identifying technical gaps while problem‑solving and leading cross‑functional teams to eliminate deficiencies. Develops and advances a culture of continuous improvement by identifying opportunities and performing analysis as well as using root‑cause investigation and risk‑based methodologies.

Deploys sourcing initiatives and controls, maintaining a strong focus on PI accounts and portfolio support. Facilitates accurate, transparent and timely communication of critical incidents and fosters cross‑disciplinary knowledge exchanges.

Requires expertise in the Quality Control Laboratory discipline and applies knowledge of internal/external business challenges to improve products and processes. Works independently with minimal guidance. Acts as a resource for…