Senior Quality Specialist

Azzur Cleanrooms on Demand™      

As you look to start your journey on the next cure that can heal patients and save lives, lack of space to manufacture and properly follow cGMP processes can be a major hurdle. To address the unique needs of start-ups in your position, Azzur Cleanrooms on Demand™ is here to support production for early-phase partners, helping you accelerate your time to market. Truly unique to the industry, our on-demand cleanrooms as a service include cGMP-compliant cleanroom space, warehousing, and materials management. This allows partners to execute manufacturing activities without the need for facility ownership or reliance on contract manufacturing organizations (CMOs). Unlike working with a CMO, Azzur Cleanrooms on Demand™ mitigates risk, affording you full access and control to your IP, space, and activities. This is all backed by quality management consultants with decades of experience implementing...

Navarro Research and Engineering is recruiting a Quality Assurance (QA) Specialist, Senior for Piketon, OH.

Navarro Research & Engineering is an award-winning federal contractor dedicated to partnering with clients to advance clean energy and deliver effective solutions for complex challenges in the nuclear and environmental fields. Joining Navarro means being a part of an exceptional team committed to quality and safety while also looking for innovative strategies to create value for the client’s success. Headquartered in Oak Ridge, Tennessee, Navarro has active programs in place across the nation for DOE/NNSA, NASA, and the Department of Defense.

Under general supervision, performs quality assurance support for the Quality Assurance (QA) team.  Typical job duties are routine and require use of standard techniques and procedures.

• Responsible for planning and preparation of quality assurance documents and procedures and...

At Editas Medicine, we are pioneering the possible. Our mission and commitment is to translate the power and potential of the CRISPR/Cas12a and CRISPR/Cas9 genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world.  Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases.  

Why Choose Editas?

At Editas Medicine, we’re a team of courageous problem solvers, harnessing the power and potential of CRISPR gene editing to transform the future of medicine. Driven by a shared purpose to serve people living with serious diseases, we succeed together through collaboration, mutual respect, and innovation. If you want to be part of a team where your voice is heard and respected, where you can operate at the forefront of gene editing, and push the boundaries of what’s possible in medicine, come join us and...

Team CATHEXIS elevates the government contracting experience through rapid response, deep skill, and thoughtful problem-solving and communication. Our core capabilities are our top-tier program and project management, data analytics, and audit services, the backbone of which is our integrated approach to operational excellence. 

You worked hard to get to where you are. You strive to make every day better than the day before. So do we. Team CATHEXIS operates with an all-in mindset. We are working together to create a company that supports our shared values and individual goals. Our values are centered around Respect, Engagement, Customer Service, Integrity, Teamwork, and Excellence in everything we do for our employees, clients, partners, and communities. We believe success is best when we listen and lead with empathy; model high standards of ethics to provide a rewarding candidate experience; work hard, have fun, and appreciate the strengths we all bring to the team; and...

Team CATHEXIS elevates the government contracting experience through rapid response, deep skill, and thoughtful problem-solving and communication. Our core capabilities are our top-tier program and project management, data analytics, and audit services, the backbone of which is our integrated approach to operational excellence. 

You worked hard to get to where you are. You strive to make every day better than the day before. So do we. Team CATHEXIS operates with an all-in mindset. We are working together to create a company that supports our shared values and individual goals. Our values are centered around Respect, Engagement, Customer Service, Integrity, Teamwork, and Excellence in everything we do for our employees, clients, partners, and communities. We believe success is best when we listen and lead with empathy; model high standards of ethics to provide a rewarding candidate experience; work hard, have fun, and appreciate the strengths we all bring to the team; and...

Verista’s 600 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do...

Cambridge Isotope Separations (CIS) has an outstanding opportunity for an experienced Quality Assurance Senior Specialist based onsite in our Xenia, OH location.  CIS is the world leader in the separation of 13C and 18O and is a subsidiary of Cambridge Isotope Laboratories (CIL) in Massachusetts, the world’s leading producer of stable isotopes and stable isotope-labeled compounds.  CIL separates both 13C and 18O at its Xenia, Ohio, facility and has the world’s largest production capacity for both 13C and 18O.  CIL also has the only large capacity nongovernmental D2O (Deuterium Oxide) enrichment columns in the world located at its CIS facility. 

Summary:

Primary responsibility of the GMP Quality Assurance Senior Specialist is to work as a team member to uphold compliance and maintenance of the Company’s cGMP (Current Good Manufacturing Practices) and Quality systems to in-house and/or external...

Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com.

Position details

Encoded is seeking a Sr. Specialist, Quality Assurance that will serve to provide Quality Assurance support for early stage gene therapy candidates. As part of the Quality Assurance group primarily responsible with providing quality oversight and support to operations at Encoded in support of manufacturing operations.

Workplace Model: Hybrid (Note: Support for manufacturing operations may require shift coverage consisting of weekdays or weekends at times.)

Responsibilities

• Provide...

Our Company: 

Congo Brands is at the epicenter of where consumer demand meets product development. Through brand partnerships with lead influencers, we are afforded an inside look at what consumers truly desire. Congo Brands is a health and wellness brand that sells supplements, fitness snacks, hydration drinks, energy drinks, and more through e-commerce and retail partnerships. Congo Brands houses some of the world’s most noted brands including Alani Nu, Prime Hydration, and 3D Energy. Congo Brands is on pace to become one of the world’s most noted consumer product companies, with revenue growth increasing exponentially year over year. Congo Brand’s goal is to be the go-to ‘Better for You Brand’ for everything from ready-to-drink beverages, snacks, supplements and more.

The Role:

Congo Brands is seeking a Senior Quality Assurance Specialist to join our team. The Senior Quality Assurance Specialist will...

At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.

We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.

Together, we are leading the way towards a healthier and more equitable future.

Position Summary

Editas is seeking a cooperative, highly motivated and experienced quality professional to support internal GMP manufacturing operations. This position will be responsible for Quality Operations support of internal clinical manufacturing at the...

Congo Brands:

Congo Brands is at the epicenter of where consumer demand meets product development. Through brand partnerships with lead influencers, we are afforded an inside look at what consumers truly desire. Congo Brands is a health and wellness brand that sells supplements, fitness snacks, hydration drinks, energy drinks, and more through e-commerce and retail partnerships. Congo Brands houses some of the world’s most noted brands including Alani Nu, Prime Hydration, and 3D Energy. Congo Brands is on pace to become one of the world’s most noted consumer product companies, with revenue growth increasing exponentially year over year. Congo Brand’s goal is to be the go-to ‘Better for You Brand’ for everything from ready-to-drink beverages, snacks, supplements and more.

The Role:

The Senior Quality Specialist will support our expansion in the Beverage, Nutrition, and Personal Care products. In this role, you...

The primary responsibility of the Senior Quality Assurance Specialist includes supporting ATEC's quality system in compliance with ISO 13485, 21CFR820, and MDSAP. This position will support audits, ad-hoc risk assessments (including HHEs), CAPAs, Quality Planning, system process development, and occasionally support Document Control and Compliance Departments. This role supports the development and operation of the Quality Management System (QMS) at Alphatec Spine. This position also supports compliance to applicable domestic and international regulatory medical device regulations such as Part 820, 7, 806, 1271, ISO 13485, Australian Therapeutic Goods (TGA), New Zealand (Medsafe), and Japan (MHLW/PMDA).

Essential Duties and Responsibilities

• Establishes systems to assure compliance with domestic (21CFR820) and international regulations (Australia: Australian Therapeutic Goods Administration, New Zealand: Medsafe, Japan: MHLW/PMDA)
• Leads...