QC Stability Specialist

Essential Duties and Responsibilities

• Coordinate daily activities for the QC analysts and other departments performing stability workflows, ensuring all activities are completed as required per the stability testing program.
• Using influence strategies to drive testing completion without direct authority over testing groups.
• Support laboratory investigations and deviations, identifying root causes and enacting effective CAPAs to improve overall laboratory performance (%RFT).
• Interact with clients both internal and external providing status updates.
• Provide support in resolving technical QC issues.
• Perform technical data review, data analysis, and trending.
• Author(s) and Revise(s) technical documentation (e.g. Stability Reports, SOPs, forms, etc.) as required.
• Implement and applies cGMP concepts in association with department specific responsibilities.
• Actively engage in continuous improvement for areas of responsibility, collaborating with other departments to identify and implement process efficiencies and workflows.
• Drive testing efficiencies in order to reduced testing time and improve compliance.
• Conflict resolution, problem solving in a cross functional setting, and ability to meet testing timelines.
• Occasional and infrequent testing support with advanced analysis and wet/physical chemistry.
• Supports audits, including laboratory walkthroughs with client and regulatory agencies.
• Other duties, as needed

Qualifications

Required

• Bachelor's degree in a scientific field with 3 or more years' experience in a CGMP / laboratory environment.
• 3+ years of relevant experience in a cGMP organization
• 2+ years stability program experience
• Experience working in a cGMP/ laboratory required.
• Experience working in a (CMO) contract manufacturing/development organization preferred.
• Ability to work independently with minimal supervision and in compliance with cGMPs.
• Scientific technical writing ability including authoring and revising SOPs or technical documents and reports.
• Must have strong attention to detail as well as ability to work in a cross-functional team environment
• Excellent organizational skills and the ability to work within a fast-paced environment
• Must have proven logic and decision-making abilities, critical thinking skills.
• Working knowledge of cGMP, ICH, USP, and global compendial regulations guidelines specifically how they pertain to stability programs.
• Proficient in Microsoft Office, Excel, and PowerPoint.
• Excellent communication and interpersonal skills are must.

Preferred

• Proficiency in standard QC laboratory equipment (HPLC, GC, FTIR, UV, KF, etc.) desirable
• Background in data trending desirable
• Excellent interpersonal skills and the ability to communicate well both orally and in in writing
• Ability to multi-task in a dynamic environment with changing priorities
• Resilient, can quickly move forward despite challenges
• A drive to achieve results for self and clients
• Positive attitude and strong team, cross team collaboration
• Honesty, integrity, respect and courtesy with leadership and peers