POSITION OBJECTIVE:         Responsible for the execution of batch record reviews and associated product quality issue resolution. Authorizes shipments from Athenex Pharmaceutical Division’s contract manufacturing organizations (CMO) once all applicable documentation has been reviewed and deemed acceptable. Reviews and coordinates the management of change control records as part of the company’s partner relationships and internal change management execution. Will provide direct support and guidance to new product launch initiatives and supply chain concerns. Ensure standards and requirements are met for all executed activities. Supports the existing quality systems, including executing SOPs and data management activities in association with the company’s management review process. Can interface with the company’s partners to clarify, assess, and/or approve product quality concerns.

Essential Job Functions/Responsibilities

·        Review and approve batch records, change controls related to cGMP documentation - deviation and investigation reports, QC data, CoA, CoC, product labeling and specification sheets, and all documentation supporting shipment of products prior to shipment, including temperature profiling data.

·        Provide guidance and support in all aspects of cGMP to our CMOs including in particular good documentation practices and root cause analysis during investigations. 

·        Ensure all applicable data is accurate, up to date, and defendable to regulatory authority.

·        Provide ongoing support to the existing Quality Management System and training programs.

·        Generate and manage validation protocols and final reports supporting packaging and shipping validation studies and temperature profile assessments.

·        Act on behalf of the Vice President or Director Quality Assurance, as designated.

Required Education & Qualifications

·        BS degree with least 3 years of progressive, challenging QA/QC experience in the pharmaceutical industry, preferably aseptic manufacturing.

·        In depth knowledge of current GMP and GLP as well as FDA trends and guidelines.

·        Must have excellent organizational and project management skills to coordinate multiple projects.

·        Strong interpersonal communication skills required – verbal, written and presentation.

·        Ability to work in a cross-functional team environment and a flexible team-oriented perspective.

·        Broad career progression within the pharmaceutical drug development and/or drug manufacturing industries strongly preferred; with specific experience in quality, regulatory, and manufacturing preferred.

·        Must possess exceptional communication and interpersonal skills.

·        Must have excellent organizational and project management skills to coordinate multiple projects.

·        Expertise in microbiology, aseptic processing, and terminal sterilization processes.

·        Possesses strong organizational skills for prioritizing workload and responsibilities.

·        Strong written communication, interpersonal, negotiations and problem-solving skills are required.

·        Ability to manage indirect relationships and projects successfully.

·        Proficient with PC – based word processors, databases and spreadsheets.

·        Attention to detail.

·        Elevates issues to management, when appropriate.

Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. 

Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.

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