QC Stability Coordinator

Hello

• This individual is responsible for executing duties to support the stability program for the Catalent CGT-Maryland sites in compliance with internal SOPs and ICH guidelines.
• This includes writing stability protocol and reports (interim and final). The individual will perform stability timepoint pulls and sample testing as needed.
• The Quality Control Stability Coordinator must demonstrate technical knowledge, be familiar with basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to quality, compliance and scientific excellence. Execution of duties for the Maryland stability program and related stability studies
• Support and assist with generation of stability SOPs, protocols and reports (interim / final). Assist with and support stability protocol, report and SOP revisions as needed
• Perform timely completion of stability timepoint pulls as per relevant protocols and stability program SOPs
• Maintain stability sample inventory and related metrics for current stability studies
• Support and assist with metrics for QC Stability in support of Management Review and investigations
• Perform stability sample shipments to contract laboratories and/or sample storage vendors
• Maintain stability chamber care, maintenance and support troubleshooting and temperature chart data interpretation
• Assist with and support stability data trending in accordance with stability program SOPs and ICH guidelines
• Perform QC testing as needed to support product release and stability studies
• Work closely with Manufacturing, Quality Control, Quality Assurance and Regulatory staff to resolve quality issues regarding the stability program.
• Document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending
• Ensures compliance with cGMP and safety requirements within the QC laboratory Participates and carries out continuous quality improvements in the QC laboratory
• Participates in project specific, system, client, and vendor audits Maintains QC analytical laboratories and facilities in an audit ready status at all times.
• Support and participate in training on applicable SOPs, regulatory requirements and quality initiatives
• Strong focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up and ability to make timely and sound decisions (Quality and Business). Must be able to prioritize.
• Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike (transversely collaborative) across functional groups and levels Ability to work within a team setting as well as independently

• Execute activities associated with the Stability Program and related SOPs
• Analyze data and complete reports with attention to detail
• Experience with LIMS, Trackwise and statistical software (.JMP) is preferred
• Apply scientific and regulatory principles in order to solve operations, as well as routine tasks, in the QC department
• Produce results in a fast-paced environment in order to meet client deadlines, and under minimal supervision
• Builds credibility within the group by performing high quality work
• Familiarity with Good Manufacturing Practices (GMPs)
• Effectively communicates results of own work through presentations, discussions, and documentation

• Bachelor in a Life Sciences discipline or equivalent experience is a minimum requirement
• 2 or more years of relevant experience and at least 1 year of stability program experience in GMP regulated laboratory preferred
• Basic knowledge relevant to stability studies, ICH guidelines related to stability, QC methods used for protein chemistry, molecular biology and microbiological testing.
• Experience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in a Quality Assurance/QC function with a basic familiarity of general GMP practices
• Experience in writing SOPs, handling QC samples and generating or supporting stability protocols and reports
• Broad experience with biochemistry, biological and microbiological assay support, as well as generating the documentation that supports such work.