Product Quality Specialist

Serve as stability point of contact for assigned API and drug product families Oversee stability sample management Author and oversee stability protocols and reports in accordance with global SOPs, including sampling strategy Support audits and regulatory filings related to stability questions Manage stability lifecycle activities Support PQI/PQO and business partners with stability‑related questions Support temperature excursions, change controls, stability notifications, and escalations Maintain stability statements for assigned products Partner with Stability Labs to address questions promptly Support Stability CoE departmental goals and continuous improvement Contribute input during staff meetings to improve stability processes Requirements Bachelor’s degree required, majoring in Pharmacy, Chemistry, Biology, Biochemistry, Engineering, or a similar technical/scientific discipline Minimum 6 years of relevant experience required Minimum 4 years of experience in the pharmaceutical, biotechnology, or medical device industry requiredPostgraduate experience and/or education counts toward years of industry experience Experience in API and drug product stability and business implications of stability decisions desired Understanding of quality processes and systems, including change control, event handling, CAPA, and risk management required Insight into pharmaceutical and/or chemical processes, product quality assurance/control, and product development and manufacturing is a plus Ability to work independently and in a team environment Relationship building as part of a team required Strong written and oral communication skills with various organizational levels Understanding of global regulatory requirements and guidelines applicable to pharmaceuticals, with ability to apply GMP regulations Flexibility to accommodate US, EMEA, and AP work schedules when vital Willingness to travel 5–10% domestically and internationally Core Competencies Demonstrates expertise in API and drug product stability management, including protocol authoring and regulatory compliance. Proficient in quality processes such as change control and risk management, with strong communication and relationship‑building skills. Highest-signal resume keywords API Stability Management Regulatory Compliance Quality Processes Pharmaceutical Industry Experience Communication Skills ATS Optimization Keywords Hard Skills Stability Sample Management Stability Protocol Authoring Change Control CAPA Risk Management Pharmaceutical Processes Product Quality Assurance Product Development GMP Regulations Temperature Excursion Management Soft Skills Team Collaboration Relationship Building Independent Work Written Communication Oral Communication Industry Keywords Pharmaceutical Industry Biotechnology Medical Device Industry Global SOPs Stability Lifecycle Activities Stability Notifications Continuous Improvement Stability CoE Audits Regulatory Filings #J-18808-Ljbffr Jobtailor