Principal QA Specialist

KBI Biopharma•Durham, NC

About The Position

Position Summary: Individual contributor and special project leader responsible for ensuring compliance with internal quality documents, regulatory requirements, and cGMP. The role will serve as Quality-to-Quality client liaison and sometimes SME for the Quality team reporting cross-QA metrics and status for KBI and clients. The role is client-facing. The role will be responsible for supporting processes required for product release, including deviation investigation guidance and CAPA review and approvals. Additionally, this will be responsible for compiling, analyzing, and reporting of associated Quality and Client metrics. The completion of the Annual Product Quality Review for commercial programs is also required. The role requires routine interactions with all functions supporting the external network, including interaction with functions across our company’s global network. The role supports activities to ensure 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.

Requirements

BS/BA Degree in Science or Engineering relevant to the pharmaceutical / Life Science or related industries AS/AA acceptable with 7-10 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 Control including solid knowledge of global GMP Quality and Regulatory requirements.
Minimum of 2 years of previous experience in QA and experience in a Client-Facing QA role.
Demonstrates solid Body of 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, Prior direct regulatory agency, and audit management /r support experience a plus.
Ability to work effectively with others and communicate in customer-facing forums to progress issues and obtain positive results.
Able to navigate conflict to achieve deliverables and drive to targeted outcomes.
Ability to resolve differing perspectives with effective negotiation.
Ability to work professionally and facilitate positive interdepartmental interactions with a diverse group of people.
Voluntarily communicates needs and suggestions clearly and effectively.
Listens and is attentive to others’ ideas and contributions.
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
Demonstrated ability to be a strong, dependable team-player, yet effective at advancing assignments and projects independently.
Demonstrated strong attention to detail and effective investigation, problem solving and organizational skills.
Ability to properly prioritize tasks, manage time effectively.
Positive proactive approach to drive projects/tasks to completion.

Nice To Haves

Project Management experience or formal training is a plus.

Responsibilities

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.
Routinely interfaces with the PMO team to ensure any Quality topics are addressed.
Serves as QA facilitator for the Quality aspect of all projects requiring QA support.
Serves as the accountable Quality lead, decision maker, and delegate for project teams and in related meetings.
Supports audit / inspection readiness of the site.
Participates in regulatory and other quality and compliance report-outs; reviews client audit outcomes to ensure appropriate corrective actions are implemented as assigned.
Serves as client liaison and quality representative on behalf of KBI in audits, client and other client facing meetings and those requiring a Quality SME where the job skills and proficiencies allow.
Supports Deviation Management activities by participating in investigational meetings, activities, writing as needed, and approving investigations.
Leads Product and Client Complaint activities in accordance with SOP and established requirements.
Supports efforts to ensure organization operates within established policies/procedures and complies with all applicable governmental regulations (cGMP, etc.), both domestic and foreign.
Operates in a safe and efficient manner and in compliance with the safety and health policy.