Senior QA Specialist, Client Support

Senior Quality Assurance Specialist – Client Support

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.

The Quality Systems team is responsible for establishing and continuously improving the Quality Management System (QMS) that supports the site and Global Compliance activities ensuring systems and business processes are robust, effective, and efficient to comply with required regulations, policies, and guidelines governing the manufacture and holding of materials for our company. The Quality Systems departments goal is support of the site teams to achieve a culture of ongoing regulatory readiness and sustained compliance that delivers safe, pure and effective materials to our clinical and commercial clients.

The Senior Quality Assurance Specialist – Client Support is a key individual contributor and client projects leader on the Quality Systems team, serving as the Quality-to-Quality client liaison. The incumbent collaborates closely with counterparts throughout the Quality team, supporting processes required to ensure compliance with internal quality documents, regulatory requirements, and cGMP for early and late phase clinical and commercial manufacturing. The incumbent will be responsible for providing support for such activities as product release, deviation, complaint and supplier investigation and closure and facilitating associated collaborations. Additionally, the incumbent will support the compilation, analyzing and reporting of associated metrics. The role requires routine interactions with all functions supporting the external network, including interaction with functions across the company's global network.

This role is an onsite hybrid role, working a schedule Monday through Friday between the hours of 8:00 am – 5:00 pm.

Responsibilities:

• Serves as QA facilitator for the Quality aspect of client projects: accountable as the Quality lead, actions coordinator and delegate for the site client project team, joint QA and related meetings.
• Provides interface between KBI Quality and client regarding batch status, Quality metrics, and Quality issues impacting batch disposition and disposition timeline.
• Communicates client concerns to KBI teams; facilitates discussions as necessary to resolve client issues. Escalates issues to leadership as needed. Interfaces with the PMO team to ensure Quality topics are addressed.
• Supports Batch disposition, fully executing the disposition process as needed.
• Supports audit / inspection readiness of the site. Participates in regulatory and other quality/compliance report-outs; reviews client audit outcomes to ensure appropriate corrective actions are implemented as assigned.
• Works with Global Compliance to support Client Audits
• Supports Deviation Management activities by participating in investigational meetings, activities, writing and approving investigation as needed.
• Assists with compiling, reviewing/approving Quality Systems and Compliance documentation and reports.
• Demonstrates knowledge of Quality Systems and functions supporting drug or related FDA governed manufacturing obtained from professional Quality roles. Includes a balance of, from such areas as Supplier Quality Assurance, Compliance, Audits/Inspections, Shop Floor Support, Batch / Material release, Quality document control, review and approval, Validation, QC, Deviations, audit support.
• Demonstrated ability to keep Project Leads, such as PMs and team members, informed of the status of assigned work. Ability to determine where escalation is necessary. Capability of being flexible as required tasks change and maintain productivity.

Requirements:

• BS/BA Degree in Science or Engineering relevant to the pharmaceutical / Life Science or related industries AS/AA acceptable with 5-7 years of relevant experience as described below.
• Minimum 5 years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance, and Quality Operations including solid knowledge of global GMP Quality and Regulatory requirements.
• Minimum of 2 years of previous experience in QA and in a Client-Facing QA or Project Management role.
• Ability to communicate in customer-facing forums to progress issues and obtain positive results.
• Ability to work professionally with others and facilitate positive interdepartmental interactions with a diverse group of people. Includes ability to navigate conflict to achieve deliverables and drive to targeted outcomes, as well as to resolve differing perspectives with effective negotiation.
• Listens and is attentive to others’ ideas and contributions.
• Demonstrated ability to be a strong, dependable team-player, yet effective at advancing assignments and projects independently. Voluntarily communicates needs and suggestions clearly and effectively.
• Demonstrated strong attention to detail and effective investigation, problem solving, and organizational skills. Ability to properly prioritize tasks and manage time effectively. Proactive approach to drive tasks to completion.
• Excellent written and verbal communication skills.
• Ability to read, write, and proofread technical documents, investigations, regulatory documents, etc.
• Ability to compile and analyze data and information from multiple sources
• Ability to perform basic calculations and data assessment, simple statistics, graphing, plotting data
• Minimum intermediate proficiency with of Microsoft Office Excel, Word, PowerPoint (Microsoft365).
• Intermediate proficiency with ERP and QMS systems required, such as SAP, TrackWise, and LIMS.
• Ability to sit for extended periods of time.
• Ability to work on site in a manufacturing environment periodically.