Senior Quality Control Research Associate II

4 hours ago

Wilmington, Ohio, United States Alkermes Full time
Job Description Background

Alkermes is seeking a highly motivated and knowledgeable Senior Quality Control Research Associate II to join our QC Technical Services group. The successful candidate will be responsible for all Microbiological/Chemistry related projects across multiple sites, including but not limited to the identification and procurement of new equipment/technologies, coordinating feasibility studies, method development and validation of methods, supporting investigations for manufacturing, writing and reviewing regulatory sections for INDs, BLA, NDA, sNDA, and other regulatory supplements, and supporting audits for regulatory agencies and customers.

Position Summary

The Senior Quality Control Research Associate II must be a competent professional who is able to network with internal colleagues and external vendor representatives, consultants and other professionals. Using this network and their own experience and expertise, they are able to develop creative and compliant solutions to challenges. They must be familiar with the common techniques and equipment within a pharmaceutical laboratory and the regulation and guidance that govern them. As the Subject Matter Expert on laboratory equipment and methods, they must be an approachable and experienced trainer capable of clearly articulating technical details.

Responsibilities

The Senior Quality Control Research Associate II will be responsible for leading specific aspects of a project, guiding solutions for difficult problems, executing project tasks, identifying best solutions based on project requirements, writing, revising or reviewing equipment and method qualification protocols/reports, engineering studies, SOP's, specifications, and assigned sections of regulatory filings, writing or reviewing deviation investigation reports and audit responses, establishing and managing relationships with equipment vendors and contract laboratories, serving as subject matter expert for training, operation and troubleshooting of select laboratory instrumentation and procedures, serving on special committees and project teams, performing backup support microbiological testing activities as needed, participating in compliance audits, investigations, and CAPA implementation, participating in resolution and approval of microbiological excursions, supporting manufacturing and validation activities including Aseptic Process Simulations/Validations and Cleaning Validations, and developing and maintaining effective working relationships with key internal/external customers.

Requirements

The ideal candidate will have a BSc in a science-related field with 4+ years' experience in pharmaceutical manufacturing or equivalent, be able to work autonomously, receiving general instructions on new assignments, have strong technical knowledge of microbiological/Chemistry test instrumentation and method development/validation including software/computer system validation, have experience with the execution and validation of test methods for sterile and non-sterile drugs, their raw materials, components and in-process testing, including the methods described in USP Chapters and relevant informational chapters, have knowledge of current compendia requirements, have excellent organizational, planning and scheduling skills, be capable of managing/coordinating multiple projects and priorities in a dynamic environment while maintaining a professional demeanor, demonstrate a systematic approach to problem solving, consider all relevant facts & data when making decisions, apply previous experience & best practices to new situations, own the results of their individual actions & team activities, be able to learn from mistakes & hold a strong belief in continuous improvements, both personally & professionally, be able to quickly change direction when business priorities or customer requirements change, exhibit a high level of flexibility when confronted with new or unexpected circumstances, have good verbal and written communication skills, be a confident presenter, clear, concise technical writer, and be familiar with common MS Office software packages.

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