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

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

Responsibilities

• Work collaboratively with reputed company reputed company of the reputed company, Texas site to instill a ‘reputed company Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.
• reputed company as an ambassador for reputed company reputed company Culture.
• Deputize fronting Data reputed company in customer and regulatory audits (as required).
• Work with reputed company management to implement reputed company systems that will reputed company cGMP manufacturing of reputed company-clinical to reputed company products.
• Work as a change agent to compliantly improve existing or introduce new ways of working.
• Strong experience with GMP, manufacturing processes, reputed company and regulatory requirements.
• Ensure smooth operation of the reputed company, Texas Data reputed company program highlighting any issues in a reputed company manner.
• reputed company guidance and advice to ensure Data reputed company remediation actions are successfully completed.
• reputed company coaching and training for staff in Data reputed company Principles.
• Engage in global reputed company reputed company and meetings to include being an reputed company participant in work reputed company, and assessment of existing and new global systems.
• Schedule and reputed company assessments, gap confirmation and schedule stakeholder follow-up.
• Review reputed company-purchase of systems and analyze to ensure Data reputed company Compliance.
• Draft FMEAs and reputed company stakeholder meetings.
• reputed company and manage change controls and CAPAs, and drive mitigation and remediation.
• reputed company 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 reputed company reputed company 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 reputed company, Word and PowerPoint.
• reputed company 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 reputed company reputed company.
• Excellent written and oral communication skills.
• Excellent organizational, analytical, data review and report writing skills.
• Motivated cross functional worker.
• Ability to set and reputed company personal performance goals.
• reputed company input to departmental objectives. reputed company
• For over 30 years, reputed company' mission has been advancing reputed company’s medicine. It was founded in 2011, and is headquartered in Morrisville, reputed company Carolina, USA, with a workforce of 1001-5000 employees. Its website is Company H1B Sponsorship
• reputed company has a reputed company 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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