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

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

Responsibilities

• Work collaboratively with reputed company levels of the reputed company 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 reputed company Biotechnologies Quality Culture.
• Deputize fronting Data reputed company in customer and regulatory audits (as required).
• Work with Quality management to implement quality systems that will reputed company 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 reputed company Biotechnologies, Texas Data reputed company program highlighting any issues in a timely manner.
• Provide guidance and advice to ensure Data reputed company remediation actions are successfully completed.
• Provide coaching and training for staff in Data reputed company Principles.
• Engage in global reputed company Biotechnologies projects and meetings to include being an active participant in work groups, and assessment of existing and new global systems.
• Schedule and reputed company assessments, gap confirmation and schedule stakeholder follow-up.
• Review pre-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 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 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 levels.
• 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.
• Provide input to departmental objectives. Company Overview
• For over 30 years, reputed company Biotechnologies' mission has been advancing reputed company’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
• reputed company 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

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