Senior QA Specialist/Principal Specialist Client Support

KBI Biopharma•Boulder, CO

7d•$90,000 - $130,000•Onsite

About The Position

This is an individual contributor and special project leader role responsible for ensuring compliance with internal quality documents, regulatory requirements, and cGMP. The incumbent will serve as a 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 incumbent will be responsible for supporting processes required for product release, including deviation investigation guidance and CAPA review and approvals. Additionally, the incumbent 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.

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 (for Principal Quality Specialist).
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 (for Principal Quality Specialist).
Minimum of 2 years of previous experience in QA and experience in a Client-Facing QA role (for Principal Quality Specialist).
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 (for Senior Quality Specialist).
Minimum 3 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 (for Senior Quality Specialist).
Minimum of 2 years of previous experience in QA and experience in a Client-Facing QA role (for Senior Quality Specialist).

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.