**Senior Associate QC Analytics:** Under minimal supervision, responsible for one or more of the following activities in QC including HPLC, CE, GELs, analytical testing, characterization, method transfer, sample and data management and equipment maintenance. • Contributes to team by ensuring the quality of the tasks/services provided by self. • Contributes to the completion of milestones associated with specific projects or activities within team This role will support manufacturing operations, as such work will be as part of a **24/7 shift pattern** and flexibility may be necessary. **Specific Job Duties:** • With a high degree of technical flexibility, work across diverse areas within the lab. • Plan and perform routine analyses with efficiency and accuracy. • Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays. • Report, evaluate, back-up/archive, trend and approve analytical data. • Troubleshoot, solve problems and communicate with stakeholders. • Initiate and/or implement changes in controlled documents. • Participate in audits, initiatives, and projects that may be departmental or organizational in scope. • Write protocols and perform assay validation and equipment qualification/ verification. • Introduce new techniques to the lab, including method transfers, reports, validations and protocols. • Evaluate lab practices for compliance and operational excellence improvement on a continuous basis. • Approve lab results. • May participate in lab investigations. • May provide technical guidance. • May train others. • May contribute to regulatory filings. • May represent the department/organization on various teams. • May interact with outside resources. **Knowledge:** • Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning • Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery • Experience in a wide variety of analytical techniques including but not limited to HPLC, Capillary Electrophoresis. **Skills:** • Take initiative to identify and drive improvements. • Excellent verbal and written communication skills. • Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls) • Presentation skills. • Decision Making skills. • Teamwork and Coaching others. • Negotiation and Influence skills. • Problem solving skills. • Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope • Ensures compliance within regulatory environment • Develops solutions to technical problems of moderate complexity • Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues • Interprets generally defined practices and methods • Able to use statistical analysis tools to perform data trending and evaluation • Project Management and organizational skills, including ability to follow assignments through to completion **Competencies:** • Demonstrated ability to work independently and deliver right first-time results • Works under minimal direction • Work is guided by objectives of the department or assignment • Follows procedures • Refers to technical standards, principles, theories and precedents as needed • May set project timeframes and priorities based on project objectives and ongoing assignments • Recognizes and escalates problems • Demonstrated leadership and communication skills • Auditing documentation and operation process • Demonstrated ability to interact with regulatory agencies **Relevant experience:** • Bachelor’s degree in a science discipline. • 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry. • Experience with regulatory compliance in GMP manufacturing and testing of pharmaceutical products