What are the responsibilities and job description for the QA Specialist position at Katalyst Healthcares & Life Sciences?
Responsibilities : Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements. Serves as Analytical Operation Lead for clinical and commercial projects. Leads quality investigations / deviations / quality event escalation meetings, and effectively communicates and escalates major and / or critical events to upper management in a timely manner. Reviews and approves method validation and / or transfer documents including protocols, reports, methods, change controls and specifications for small molecules and / or large biologics for analytical operations, and contract labs / manufacturers across the clinical and commercial supply chains. Reviews manufacturing records, environmental monitoring and quality control data for in-process and finished products. Reviews and audits method validation related data in CMC sections of NDA / global filings. Responsible for maintaining current knowledge of Compliance program and of applicable company standard operating procedures for areas of responsibility. Interfaces with operating entities and contract partners to address documentation and compliance issues and ensure successful project completion. Leads department projects of varying complexity. Reviews and improves existing quality procedure workflows, identifies areas of improvement for efficiency and compliance. Acts as an Analytical QA subject matter expert in support of regulatory inspections and internal audits. As a quality functional site lead at CTLs, supports quality initiatives and responsible for providing quality metrics, trend reviews, and risk assessments. Participates in projects, initiatives, and process improvements. May conduct or serve as a lead / coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products. May assist with cGMP compliance audits at contract partners and may interface with regulatory agencies during inspections. Requirements : Possesses experience / knowledge in laboratory controls, method validation and method transfer guidelines per FDA / EU / ICH / USP / JP guidelines. Strong background in laboratory investigations (OOS, OOT, Atypical), deviations and associated CAPAs. Proficient in application of FDA OOS Guidance, MHRA OOS Guidance and general QA principles, concepts, industry practices, and standards. Proficient in Root Cause Analysis Tools (e.g. Fishbone Diagrams and Failure Mode Effects Analysis, 5 Whys). Working knowledge of Risk Management Tools (e.g. root cause analysis, decision trees, risk registers). Experience in a Pharma / Biotech GMP environment and a bachelor's degree in chemistry, biology, or related scientific field. Expertise in Quality Systems and cGMP standards applicable to method validation for clinical and commercial products and AO / QC laboratory operations. Demonstrates excellent verbal, written, and interpersonal skills. Demonstrates excellent organizational skills and ability to work on several projects to tight timelines. Demonstrates ability to effectively manage multiple projects / priorities. Demonstrates excellent attention to detail, and ability to consistently meet high standards of quality required in QA Compliance. Ability to work independently and effectively coach peers in a high-paced environment with tight timelines, while maintaining accuracy and quality. Possesses critical thinking skills when making sound quality decisions based on risk management and available data. Has proven analytical and conceptual skills. Ability to effectively generate metrics, and present; data, findings, and improvement initiatives / projects to QA and cross-functional leadership.
