Mackinnon Bruce International’s Post

#hiring Quality Assurance Specialist, Austin, United States, fulltime #jobs #jobseekers #careers #Austinjobs #Texasjobs #ScienceTechnology Apply: https://lnkd.in/gYxDRaXN Job Description Quality Assurance Specialist Job Description Maintain a safe, fast-paced, and positive laboratory environment. Interact directly with clients on an as-needed basis. Assist in training of other personnel as requested. Ensure safety and compliance with governmental regulations. Interact with FDA and clients as needed in the event of an inspection/audit. Follow all applicable Good Clinical Practice Regulations. Generally monitor studies to assure Management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with Good Clinical Practice Standards. For any given study, be entirely separate from and independent of the personnel engaged in the direction and conduct of that study. Conduct inspections and maintain records or inspecting studies at adequate intervals and maintain written and properly signed records of each analytical/in-phase or periodic inspection. Report any problems which are likely to affect study integrity to the Principal Investigator and Management immediately. Maintain a copy of a master schedule of all studies, include all pertinent information. Maintain copies of all protocols pertaining to all studies for which the unit is responsible. Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation. Review all Adverse Events and Serious Adverse Events reported. These are reviewed for accuracy, completion, and ensured to be communicated to the Study Sponsor and IRB

#hiring Quality Assurance Specialist, Austin, United States, fulltime #jobs #jobseekers #careers #Austinjobs #Texasjobs #ScienceTechnology Apply: https://lnkd.in/gam6ezuj Job Description Quality Assurance Specialist Job Description Maintain a safe, fast-paced, and positive laboratory environment. Interact directly with clients on an as-needed basis. Assist in training of other personnel as requested. Ensure safety and compliance with governmental regulations. Interact with FDA and clients as needed in the event of an inspection/audit. Follow all applicable Good Clinical Practice Regulations. Generally monitor studies to assure Management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with Good Clinical Practice Standards. For any given study, be entirely separate from and independent of the personnel engaged in the direction and conduct of that study. Conduct inspections and maintain records or inspecting studies at adequate intervals and maintain written and properly signed records of each analytical/in-phase or periodic inspection. Report any problems which are likely to affect study integrity to the Principal Investigator and Management immediately. Maintain a copy of a master schedule of all studies, include all pertinent information. Maintain copies of all protocols pertaining to all studies for which the unit is responsible. Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation. Review all Adverse Events and Serious Adverse Events reported. These are reviewed for accuracy, completion, and ensured to be communicated to the Study Sponsor and IRB

#hiring Quality Assurance Specialist, Austin, United States, fulltime #jobs #jobseekers #careers #Austinjobs #Texasjobs #ScienceTechnology Apply: https://lnkd.in/dEG3giqd Job Description Quality Assurance Specialist Job Description Maintain a safe, fast-paced, and positive laboratory environment. Interact directly with clients on an as-needed basis. Assist in training of other personnel as requested. Ensure safety and compliance with governmental regulations. Interact with FDA and clients as needed in the event of an inspection/audit. Follow all applicable Good Clinical Practice Regulations. Generally monitor studies to assure Management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with Good Clinical Practice Standards. For any given study, be entirely separate from and independent of the personnel engaged in the direction and conduct of that study. Conduct inspections and maintain records or inspecting studies at adequate intervals and maintain written and properly signed records of each analytical/in-phase or periodic inspection. Report any problems which are likely to affect study integrity to the Principal Investigator and Management immediately. Maintain a copy of a master schedule of all studies, include all pertinent information. Maintain copies of all protocols pertaining to all studies for which the unit is responsible. Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation. Review all Adverse Events and Serious Adverse Events reported. These are reviewed for accuracy, completion, and ensured to be communicated to the Study Sponsor and IRB

#hiring Quality Assurance Specialist, Austin, United States, fulltime #jobs #jobseekers #careers #Austinjobs #Texasjobs #ScienceTechnology Apply: https://lnkd.in/dEG3giqd Job Description Quality Assurance Specialist Job Description Maintain a safe, fast-paced, and positive laboratory environment. Interact directly with clients on an as-needed basis. Assist in training of other personnel as requested. Ensure safety and compliance with governmental regulations. Interact with FDA and clients as needed in the event of an inspection/audit. Follow all applicable Good Clinical Practice Regulations. Generally monitor studies to assure Management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with Good Clinical Practice Standards. For any given study, be entirely separate from and independent of the personnel engaged in the direction and conduct of that study. Conduct inspections and maintain records or inspecting studies at adequate intervals and maintain written and properly signed records of each analytical/in-phase or periodic inspection. Report any problems which are likely to affect study integrity to the Principal Investigator and Management immediately. Maintain a copy of a master schedule of all studies, include all pertinent information. Maintain copies of all protocols pertaining to all studies for which the unit is responsible. Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation. Review all Adverse Events and Serious Adverse Events reported. These are reviewed for accuracy, completion, and ensured to be communicated to the Study Sponsor and IRB

#hiring Quality Assurance Specialist, Austin, United States, fulltime #jobs #jobseekers #careers #Austinjobs #Texasjobs #ScienceTechnology Apply: https://lnkd.in/gm8v8JxT Job Description Quality Assurance Specialist Job Description Maintain a safe, fast-paced, and positive laboratory environment. Interact directly with clients on an as-needed basis. Assist in training of other personnel as requested. Ensure safety and compliance with governmental regulations. Interact with FDA and clients as needed in the event of an inspection/audit. Follow all applicable Good Clinical Practice Regulations. Generally monitor studies to assure Management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with Good Clinical Practice Standards. For any given study, be entirely separate from and independent of the personnel engaged in the direction and conduct of that study. Conduct inspections and maintain records or inspecting studies at adequate intervals and maintain written and properly signed records of each analytical/in-phase or periodic inspection. Report any problems which are likely to affect study integrity to the Principal Investigator and Management immediately. Maintain a copy of a master schedule of all studies, include all pertinent information. Maintain copies of all protocols pertaining to all studies for which the unit is responsible. Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation. Review all Adverse Events and Serious Adverse Events reported. These are reviewed for accuracy, completion, and ensured to be communicated to the Study Sponsor and IRB

Navigating the complexities of Quality Control (QC) in the pharmaceutical industry requires not just a keen eye for detail, but also a partner who truly understands the intricacies of the field. As a Technical Resourcer at LSC, my focus is on connecting QC professionals with opportunities that not only match their skill set but also propel their careers forward. For QC professionals looking to advance their careers, consider these five must-haves: 1. Regulatory Knowledge: Stay updated with FDA, EMA, and other regulatory bodies' guidelines. This knowledge is crucial for ensuring compliance and maintaining the highest quality standards. 2. Analytical Skills: A robust understanding of analytical techniques and the ability to interpret data accurately are essential for making informed decisions that impact product quality. 3. Attention to Detail: Precision is key in QC. A meticulous approach to your work can prevent costly errors and ensure product integrity. 4. Communication Skills: Clear and effective communication is vital when collaborating with cross-functional teams and when documenting processes and outcomes. 5. Continuous Improvement Mindset: The pharmaceutical industry is ever-evolving. Embrace ongoing learning and adaptability to stay ahead in your field. If you are a QC professional, looking for a new opportunity, connect with me to discover what opportunities await you!

🔬✅ Quality control and quality assurance are crucial for accuracy and reliability in the clinical laboratory. Here are some key details: 1️⃣ Quality Control (QC) Measures: Control samples are used to monitor test accuracy and precision alongside patient samples at regular intervals. #QualityControl #ClinicalLab 2️⃣ Types of QC: Internal QC involves routine monitoring within the lab, while external QC involves proficiency testing programs by external organizations. #InternalQC #ExternalQC 3️⃣ Quality Assurance (QA) Activities: QA encompasses overall quality management, regulatory compliance, and process improvement. #QualityAssurance #LabManagement 4️⃣ Accreditation and Regulatory Requirements: Meeting specific standards ensures high-quality testing practices and reliable results. #Accreditation #RegulatoryStandards 5️⃣ Proficiency Testing: Blind samples from external organizations evaluate a lab's performance, identifying areas for improvement. #ProficiencyTesting #LabPerformance 6️⃣ Documentation and Record Keeping: Accurate and transparent documentation of QC results, maintenance records, and corrective actions is crucial. #Documentation #Transparency 7️⃣ Continuous Improvement: Labs should constantly evaluate and improve processes, equipment, and training to stay updated. #ContinuousImprovement #LabExcellence By implementing robust QC and QA measures, clinical labs ensure accurate results, contributing to patient safety and quality healthcare outcomes. 👩⚕️🌟 #ClinicalLabExcellence #PatientSafety

🌟 Navigating your QC career? As a Technical Resourcer with a niche in Quality Control, my expertise lies in connecting QC professionals with career-defining opportunities. For QC professionals aiming to advance, consider these essential must-haves: 1. In-depth Knowledge of Regulatory Requirements: Stay abreast of GMP guidelines and industry standards to excel in QC roles. 2. Strong Analytical Skills: The ability to interpret complex data is pivotal in enhancing decision-making processes. 3. Attention to Detail: Meticulousness is key in QC to ensure product quality and compliance. 4. Effective Communication: Clear communication with cross-functional teams is vital for successful QC operations. 5. Continuous Learning: Embrace ongoing training and professional development to stay ahead in the dynamic pharmaceutical landscape. Are you a QC professional seeking new avenues for growth? Reach out for a confidential discussion on current opportunities we are actively recruiting for. Let's explore how your skills and aspirations align with our exclusive roles. #QualityControl #PharmaceuticalIndustry #CareerOpportunities 🌟

Interviews can be daunting, especially in the highly regulated world of Medical Device manufacturing. Here are my top 5 tips for candidates stepping into Quality Assurance (QA) roles: 1. **Know the Regulations**: Familiarize yourself with the relevant regulations such as FDA's Quality System Regulation (QSR), ISO 13485, and EU MDR. Understand how they impact QA processes. This knowledge not only demonstrates your expertise but also shows your commitment to quality and compliance. 2. **Speak the Language of Quality**: Be prepared to discuss key quality concepts like CAPA (Corrective and Preventive Action), risk management, validation, and verification. Articulate how you've applied these in past roles or how you would in hypothetical scenarios. 3. **Detail-Oriented Examples**: Bring specific examples of how your attention to detail has made a difference in past projects. Whether it's catching a documentation error or improving a testing process, these stories will illustrate your value to the team. 4. **Continuous Improvement Mindset**: Show that you're not just about maintaining standards, but also about raising the bar. Discuss how you stay updated with industry trends and how you've contributed to continuous improvement initiatives in the past. 5. **Soft Skills Showcase**: QA roles involve cross-functional collaboration, so highlight your communication and teamwork skills. Discuss how you've worked with other departments to ensure quality and compliance. Remember, it's not just about technical know-how; it's about fitting into a culture that prioritizes patient safety through rigorous quality assurance. Good luck! #QualityAssurance #MedicalDevices #JobInterviewTips

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