Background

Requires a highly motivated and knowledgeable associate for the QC Technical Services group. The associate will be responsible for all Microbiological/Chemistry related projects across multiple sites which includes but is 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 Sr. QC 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.

The individual will have the responsibility for technical support of existing in-process and release assays, and assist with the introduction of new Rapid Methods. This position is responsible for providing strong scientific and validation input for all projects within the Microbiology/Chemistry Technical Services group, e.g., implementation of instrumentation, method transfers and validations, and other compendia tests. This position requires cross-functional collaboration with other departments including Manufacturing, Process Development, Validation, and Quality to provide support of site validation studies, microbial studies, and new product(s) implementation.

Qualifications

· BSc In science related field with 4+ years’ experience in pharmaceutical manufacturing or equivalent

· Able to work autonomously, receiving general instructions on new assignments.

· Strong technical knowledge of microbiological/ Chemistry test instrumentation and method development / validation including software/computer system validation.

· Experience with the execution and validation of test methods for sterile and non-sterile drugs, their raw materials, components and in-process testing. This includes the methods described in USP Chapters and relevant informational chapters.

· Knowledge of current compendia requirements.

· Excellent organizational, planning and scheduling skills: Capable of managing/coordinating multiple projects and priorities in a dynamic environment while maintaining a professional demeanor.

· Critical, Fact-Based Decision Making: Demonstrates a systematic approach to problem solving; considers all relevant facts & data when making decisions; applies previous experience & best practices to new situations.

· Personally Accountable: Owns the results of their individual actions & team activities. Ability to learn from mistakes & holds a strong belief in continuous improvements, both personally & professionally.

· Agility: Able to quickly change direction when business priorities or customer requirements change; exhibits a high level of flexibility when confronted with new or unexpected circumstances

· Good verbal and written communication skills; confident presenter, clear, concise technical writer.

· Familiar with common MS Office software packages.

The primary responsibilities of the position are:

· Lead specific aspects of a project, guide solutions for difficult problems, execute project tasks. Identify best solutions based on project requirements.

· Write, revise or review equipment and method qualification protocols/reports, engineering studies, SOP’s, specifications, and assigned sections of regulatory filings.

· Write or review deviation investigation reports and audit responses.

· Establish and manage relationships with equipment vendors and contract laboratories.

· Serve as subject matter expert for training, operation and troubleshooting of select laboratory instrumentation and procedures

· Serve on special committees and project teams

· Performs backup support microbiological testing activities as needed.

· Participates in compliance audits, investigations, and CAPA implementation. Participates in resolution and approval of microbiological excursions.

· Supports manufacturing and validation activities including Aseptic Process Simulations/Validations and Cleaning Validations.

· Develops and maintains effective working relationships with key internal/external customers.

Personal Attributes

· Motivated self-starter

· Team player

· Committed to quality

· Well organized, efficient worker

· Good problem solver

· Critical, analytical thinker

· Manages multiple duties and projects

· Creative, innovative thinker

· Easily adaptable to change

· Brings closure to work in a timely manner

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