Senior QA Specialist/Principal Specialist Client Support

Individual contributor and special project leader responsible for ensuring compliance with internal quality documents, regulatory requirements, and cGMP. The incumbent will serve as Quality-to-Quality client liaison and subject-matter expert for the Quality team, reporting cross-QA metrics and status for KBI and clients. This is a client-facing role.

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.
• Compiles, analyzes, and reports associated Quality and Client metrics.
• Completes the Annual Product Quality Review for commercial programs.

Requirements

Principal Quality Specialist

• 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.
• Minimum 5 years prior experience in the Pharmaceutical/Biotechnology industry with 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.
• Project Management experience or formal training is a plus.

Senior 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.
• Minimum 3 years prior experience in the Pharmaceutical/Biotechnology industry with 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.

Pay

• Senior Quality Specialist: $90,000 – $115,000
• Principal Quality Specialist: $100,000 – $130,000

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range.

Benefits

• Annual bonus structure for all employees
• Medical, dental, and vision coverage
• Paid PTO and holidays
• Sabbatical program
• 401K matching with 100% vesting in 60 days
• Employee recognition programs