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Principal QA Compliance Specialist

KBI Biopharma

This is a Full-time position in Boulder, CO posted April 7, 2021.

Job Descriptionn n JOB SUMMARY: n Support programs to monitor and evaluate the effectiveness of KBI Biopharma’s Pharmaceutical Quality System.

Implements change, as required, to ensure compliance to cGMP requirements.n n JOB RESPONSIBILITIES: This role will contribute significantly to the management and execution of Quality Systems and Programs, will author or contribute to the procedures governing these systems and will work towards timely implementation.

Manage the internal audit program at a local KBI Biopharma (KBI) site.

Evaluate audit responses for adequacy, including root cause, timeliness as well as utilizes knowledge to facilitate appropriate corrective action.

Support the internal audit program at other KBI Biopharma (KBI) sites, including acting as a lead auditor, support auditor, or resource.

Communicate results of audits to department management.

Assist with the management of client audits and health authority inspections at KBI.

Assists with the preparation of regulatory agency inspections and/ or responses to external observations.

Responsible for inspection readiness workstreams and remediation activities as applicable to ensure site is inspection-ready at all times.

Supporting the Site Management Review program by ensuring the development and maintenance of information systems for tracking and trending pertinent data for quality system performance and/or improvements.

Prepares metrics and summaries to effectively communicate status and recommendations to Senior Management.

Responsible for Quality System metrics.

Assist with the management of the Quality Risk Management Program.

Support KBI QRM Site Lead in facilitation and management of monthly QRM governance.

Support Site leadership with the Management of Quality Agreements across the organization.

Drives consistency with content and details.

Works with colleagues internally and at other KBI sites to ensure corporate compliance and implementation of corporate policies in site specific procedures.

Supports evaluations to ensures that appropriate site policies, procedures and documentation are in place to support Quality Systems according to US, JP and EU regulatory requirements.

Participates in special projects as needed.

MINIMUM REQUIREMENTS: BA/BS in life sciences (Biology, Chemistry preferred) or a combination of education and experience.

A minimum of five (5) years’ experience in the pharmaceutical or biopharmaceutical industry required.

Prior experience leading or managing audit / inspection programs within a regulated environment preferred.

A minimum of three years of relevant experience in a Quality function (QC or QA) or Manufacturing is also required or an equivalent combination of education and experience.

Solid experience executing Quality Systems.

Additional experience in manufacturing, Quality Control or Technical Operations within the biotechnology industry is a plus.

Travel Requirement: Minimal Travel nKBI Biopharma, Inc.

is an EEO/AA employer and actively seeks to diversify its work force.

Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.n nRead More