QA Specialist II, SQM

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. Position Summary: Assures that suppliers and raw materials are suitable for their intended use in clinical and commercial manufacturing. Responsible for compliance with regulations, procedures, and systems that govern the supplier approval, material qualification programs, along with ongoing supplier/material compliance. Supports client audits and regulatory inspections as needed. Support vendor complaint generation and resolution, along with evaluation and internal processing of vendor changes Responsibilities:

• Contribute and adhere to Supplier Quality Management systems and compliance activities.
• Participate in Improvement initiatives, within the SQM functional area.
• Under moderate supervision, complete multiple assigned functions in the SQM Compliance Area:
• Assist Supplier Quality Management to ensure Suppliers, Materials/Services are suitable for their intended use by conducting routine evaluations (desk/remote/onsite/for-cause audits, annual assessments, etc.).
• Auditor certification required (ex. ASQ or equivalent)
• Assist with Quality Agreement assessments and revisions through supplier communications, to ensure documents are current and compliant.
• Work with internal department personnel (ex. MSAT, QA/QCRM, Manufacturing, AFS, PD, etc.) to onboard new suppliers and materials.
• Assist with client project material qualification plans through review of the listed materials, alignment with ETQ material profiles, participation in project meetings, review and upload of material qualification data in EtQ, approval of material profiles, and periodic review of material profiles associated with assigned projects.
• Support and process supplier complaints (SCNs) and Vendor Change Notifications (VCNs).
• Support SQM related Deviations, CAPAs, and Change Controls as appropriate.

Requirements:

• BS/BA +3 or >5 years relevant experience or combination of education and experience within a QA or cGMP environment in biopharmaceuticals or equivalent, including previous pharmaceutical supplier quality experience.
• Auditor certification or demonstrated supplier/internal auditing experience.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedures. Ability to effectively present information and respond to questions from staff, colleagues, managers, and clients. Ability to read, analyze, and author complex documentation.
• Ability to travel domestically and internationally, where needed, for supplier audits.
• Ability to travel ~10-15% for onsite supplier audits and site-to-site meetings where applicable.

Salary Range: $74,000 - $102,300 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. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com. KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. KBI 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. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal. Apply tot his job Apply To this Job