[Remote] QA Specialist III, Quality Systems/Data Integrity (On-Site in College Station, TX)

Note: The job is a remote job and is open to candidates in USA. FUJIFILM Biotechnologies is seeking a proactive and driven QA Specialist III for Data Integrity to support their Data Integrity projects in Texas. The role involves managing the Data Integrity Program, performing assessments, and ensuring compliance with quality systems and regulations.

Responsibilities

• Work collaboratively with all levels of the FUJIFILM Biotechnologies, Texas site to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.
• Act as an ambassador for FUJIFILM Biotechnologies Quality Culture.
• Deputize fronting Data Integrity in customer and regulatory audits (as required).
• Work with Quality management to implement quality systems that will enable cGMP manufacturing of pre-clinical to commercial products.
• Work as a change agent to compliantly improve existing or introduce new ways of working.
• Strong experience with GMP, manufacturing processes, quality and regulatory requirements.
• Ensure smooth operation of the FUJIFILM Biotechnologies, Texas Data Integrity program highlighting any issues in a timely manner.
• Provide guidance and advice to ensure Data Integrity remediation actions are successfully completed.
• Provide coaching and training for staff in Data Integrity Principles.
• Engage in global FUJIFILM Biotechnologies projects and meetings to include being an active participant in work groups, and assessment of existing and new global systems.
• Schedule and perform assessments, gap confirmation and schedule stakeholder follow-up.
• Review pre-purchase of systems and analyze to ensure Data Integrity Compliance.
• Draft FMEAs and lead stakeholder meetings.
• Raise and manage change controls and CAPAs, and drive mitigation and remediation.
• All other duties as assigned. Skills
• Bachelor’s degree with 3+ years of experience in Pharmaceutical, Biotechnology or other regulated Industry.
• Master’s Degree with 1+ years experience in Pharmaceutical, Biotechnology or other regulated Industry.
• Involvement in Data Integrity projects during previous roles.
• Strong understanding of 21 CFR Part 11 and Annex 11 regulations, FDA, GMP, GAMP and ISPE.
• Ability to multitask and easily prioritize work.
• Ability to work independently with little supervision.
• Proficient in bolthires Excel, Word and PowerPoint.
• All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.
• Ability to collaborate effectively with stakeholders from across the business, at all levels.
• Excellent written and oral communication skills.
• Excellent organizational, analytical, data review and report writing skills.
• Motivated cross functional worker.
• Ability to set and achieve personal performance goals.
• Provide input to departmental objectives. Company Overview
• For over 30 years, FUJIFILM Biotechnologies' mission has been advancing tomorrow’s medicine. It was founded in 2011, and is headquartered in Morrisville, North Carolina, USA, with a workforce of 1001-5000 employees. Its website is Company H1B Sponsorship
• FUJIFILM Biotechnologies has a track record of offering H1B sponsorships, with 1 in 2021. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job Apply tot his job

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