๐บ๐ธ ๐๐๐ฉ๐ฉ๐ฒ ๐๐ง๐๐๐ฉ๐๐ง๐๐๐ง๐๐ ๐๐๐ฒ ๐๐ซ๐จ๐ฆ ๐ญ๐ก๐ ๐ญ๐๐๐ฆ ๐๐ญ Systems Ally ๐ We're passionate about medical devices, pharma, biotech, healthcare, automotive, semiconductor and tech industry. Wishing everyone a day filled with celebration and freedom. #IndependenceDay #SystemsAlly
Systems Ally
Medical Equipment Manufacturing
Better together ๐ - your requirements ๐, our expertise ๐ก (Life Sciences & IT consulting and workforce solutions)
About us
๐๐ฒ๐ฌ๐ญ๐๐ฆ๐ฌ ๐๐ฅ๐ฅ๐ฒ is your go-to partner for top-notch global workforce solutions in the dynamic realms of medical devices ๐ฉบ, pharma ๐, biotech ๐งฌ, and IT ๐ฅ๏ธ. We specialize in providing both contingent and permanent resources to fuel innovation and drive success in your projects. Unlock the full potential of your projects with @Systems Ally! ๐ ๐ญ ๐๐๐ง๐ฎ๐๐๐๐ญ๐ฎ๐ซ๐ข๐ง๐ ๐๐ฑ๐๐๐ฅ๐ฅ๐๐ง๐๐: - Quality Control & Assurance (Pharma, Medical devices) - Validation (CSV, Cleaning, Equipment, Process) - Six Sigma (Lean, Kaizen, DFSS, DMAIC, Kanban, Continuous Improvement) - Statistics (SPC, CpK, Cpp, Minitab, JMP) - Mechanical (Solidworks, GD&T, Gage R&R, Electro-mechanical) - Manufacturing Compliance (CAPA, ISO 13485, 21 CFR 820, cGMP) ๐ ๐๐๐ ๐ฎ๐ฅ๐๐ญ๐จ๐ซ๐ฒ ๐๐ซ๐จ๐ฐ๐๐ฌ๐ฌ: - Regulatory Affairs (Submission & Publishing: 510K, PMA, CMC, eCTD, and more) - Supplier Quality (Non-conformances, Supplier Audit) ๐ง ๐๐ง๐ง๐จ๐ฏ๐๐ญ๐ข๐จ๐ง & ๐๐๐ฏ๐๐ฅ๐จ๐ฉ๐ฆ๐๐ง๐ญ: - R&D Engineering - Project Management (Agile, Scrum, PMP) - Software Testing (QA) and Business Analysis ๐ ๐๐ข๐จ๐ญ๐๐๐ก ๐๐ซ๐ข๐ฅ๐ฅ๐ข๐๐ง๐๐: - Bioprocessing - Cell Culture - Downstream Processing - Biomanufacturing ๐ ๐๐ก๐๐ซ๐ฆ๐ ๐๐ฑ๐๐๐ฅ๐ฅ๐๐ง๐๐: - Drug Development - Formulation - Drug Safety and Pharmacovigilance - GMP Compliance ๐ฉบ ๐๐๐๐ข๐๐๐ฅ ๐๐๐ฏ๐ข๐๐ ๐๐๐ฌ๐ญ๐๐ซ๐ฒ: - Design Control - Risk Management - Usability Engineering - 510(k) Submissions - Product Lifecycle Management โจ Our Tailored Solutions: Through strategic consulting, cutting-edge technology, staffing support, and comprehensive training services, we ensure your projects run smoothly. Let us handle the complexities, allowing you to focus on the vital mission of developing life-saving therapies. ๐ ๐ฑ Innovative Work Models: We're not just about services; we specialize in innovative working models for staffing and consulting companies. From MSP (Managed Service Provider) to SOW (Statement of Work), we've got your back.
- Website
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http://www.systemsally.com
External link for Systems Ally
- Industry
- Medical Equipment Manufacturing
- Company size
- 51-200 employees
- Headquarters
- Austin
- Type
- Privately Held
Locations
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Primary
Austin, US
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Boston, US
Employees at Systems Ally
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Your life science recrutiment
Recruitment Specialist at Systems Ally LLC
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Rajveer Singh
Hiring for OPT, CPT, STEM OPT, H4 EAD, GC EAD, US CITIZENS, DAY1 CPT candidates
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Vijay Rajput ๐จ
Talks about medical device/pharmaceutical/biotech positions,
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Vishal Meena
I help medical devices/pharma clients and vendors (AVAILABLE - Medical devices & Pharma candidates) It's my Job to get you a Job!
Updates
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This Memorial Day, we pause to remember and honor the brave men and women who have made the ultimate sacrifice for our country. Systems Ally As a consulting, staffing, and recruiting firm specializing in medical devices, pharma engineering, and regulatory affairs, we deeply appreciate the values of dedication and service. While we work tirelessly to connect top talent with leading companies in the medical and pharmaceutical industries, we are mindful that our freedoms and opportunities are protected by those who serve in the armed forces. Today, we extend our gratitude to all service members and their families. Let us reflect on the true meaning of Memorial Day and remember those who have given everything. #memorialday #2024
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The future of biotech isn't AI, then what is it? Continue reading... Regeneron's CEO recently emphasized the transformative potential of gene therapy in biotechnology. In an insightful CNBC article, the CEO discusses how gene therapy is poised to revolutionize the industry. Here's a concise summary to engage our LinkedIn community: ๐งฌ Unlocking Biotech's Future: Regeneron's CEO highlights gene therapy as the upcoming frontier in biotechnology, with the potential to revolutionize medical treatments. ๐ก Innovation at Regeneron: The article sheds light on Regeneron's commitment to innovation, positioning itself at the forefront of groundbreaking advancements in gene therapy. ๐ Read the Full Article: Dive deeper into the details by checking out the complete CNBC article here: https://lnkd.in/gSGP-mBt ๐ Join the Conversation: What are your thoughts on gene therapy's impact on 'biotech'? Share your insights and engage with fellow professionals. Please like the post and comment below. For weekly updates and jobs in "Pharma", "Medical Devices" and "Biotech", please follow us!
Regeneron CEO says the next big thing for biotech isn't AI
cnbc.com
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Honoring the legacy of Martin Luther King Jr. today and every day. His vision for equality and justice continues to inspire positive change. #MLKDay #equalityforall
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๐&๐ ๐ญ๐จ ๐๐ฎ๐ซ๐๐ก๐๐ฌ๐ ๐๐ฎ๐ฆ๐จ๐ซ-๐๐ง๐ญ๐ข๐๐จ๐๐ฒ ๐๐ข๐จ๐ญ๐๐๐ก ๐๐ฆ๐๐ซ๐ฑ ๐๐จ๐ซ $2 ๐๐ข๐ฅ๐ฅ๐ข๐จ๐ง Johnson & Johnson (J&J) has recently announced its acquisition of Ambrx Biopharma Inc. for a significant sum of $2 billion in cash. Ambrx Biopharma, a San Diego-based biotechnology company, is known for its development of targeted drugs for cancer, particularly tumor-antibody biotechnology. This strategic move by J&J aims to bolster its portfolio with promising targeted cancer therapies. The deal includes gaining access to Ambrx Biopharma's pipeline of drugs designed to target tumors, making it a valuable addition to J&J's efforts in advancing cancer treatment. The acquisition reflects the pharmaceutical giant's commitment to expanding its capabilities in the oncology field. This announcement comes as part of J&J's broader strategy to invest in innovative therapies and technologies that address critical healthcare needs. The targeted cancer therapy developer, Ambrx, with its expertise in antibody-drug conjugates, aligns with J&J's mission to enhance patient outcomes in the realm of oncology. The $2 billion acquisition signifies a substantial investment by J&J in the pursuit of cutting-edge cancer treatments, showcasing the company's dedication to making advancements in the field of biopharmaceuticals. ๐ Follow & Connect with us Systems Ally for weekly updates and exciting job opportunities in the ๐ฅ medical devices, ๐ pharma, ๐ฌ biotech, and ๐ tech industries! ๐ผโจ Comment below to receive more information on these amazing opportunities! ๐ #CareerGrowth #JobAlerts #StayConnected ๐ค
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The FDA has been working towards harmonizing its ๐๐ฎ๐๐ฅ๐ข๐ญ๐ฒ ๐๐ฒ๐ฌ๐ญ๐๐ฆ ๐๐๐ ๐ฎ๐ฅ๐๐ญ๐ข๐จ๐ง (๐๐๐), 21 ๐๐ ๐ ๐๐๐ซ๐ญ 820, with the international standard ๐๐ฎ๐๐ฅ๐ข๐ญ๐ฒ ๐๐๐ง๐๐ ๐๐ฆ๐๐ง๐ญ ๐๐ฒ๐ฌ๐ญ๐๐ฆ๐ฌ ๐๐๐ 13485. This alignment aims to streamline regulatory requirements for medical devices. Here's a brief overview with the latest updates for 2024: ๐๐๐๐ค๐ ๐ซ๐จ๐ฎ๐ง๐: The FDA proposed amendments to 21 CFR Part 820 in February 2022, intending to harmonize it with ISO 13485. The new regulation, known as Quality Management System Regulation (QMSR), will incorporate ISO 13485 requirements. ๐๐ข๐ฆ๐๐ฅ๐ข๐ง๐: The FDA is on track to release the final rule in December 2024, signifying the culmination of efforts to align with ISO 13485. This harmonization aims to enhance global regulatory consistency. ๐๐ง๐ ๐จ๐ข๐ง๐ ๐๐๐ฏ๐๐ฅ๐จ๐ฉ๐ฆ๐๐ง๐ญ๐ฌ: As of November 2023, the finalization of non-harmonized regulations for combination products is pending. In 2024, FDA is still expecting to finalize a rule updating its Quality Management System Regulation, which aims to harmonize 21 CFR 820 to the ISO 13485 standard. The FDA's commitment to aligning with international standards reflects a broader effort to ensure the safety and effectiveness of medical devices in the global market. ๐ Follow and Connect with Us for Weekly Updates in Medical Devices, Pharma, Biotech, and Tech Industry. ๐ก Please Comment Below to Get Additional Information on the Above Topic.