Manager, Quality Assurance

The Tsui Group is seeking a candidate with proven experience in working on complex, multi‐phase, multi‐million dollar design and construction projects to provide as-needed, lessons learned facilitation and support services. The candidate must be flexible and able to assist the Program Management Office in the daily tasks of managing the Lessons Learned Program. Assignments to include Lessons Learned workshop preparation, facilitation, and Lessons Learned Registers for database. The Lessons Learned database will provide potential risk areas to focus attention and resources. They key is to focus the discussion of the item on what occurred and the discussion of the area of improvement on how this item could have been mitigated. 

The candidate must also be able to demonstrate a professional demeanor, and have a clear understanding of project cost, schedule, documentation, and risk assessment principles, and able to multi‐task and work in a fast‐paced work environment. ...

• Conduct non conformance, product complaints, out-of-specification investigation and provide corrective and preventive actions with follow-ups.
• Trains and supervises document review personnel; batch release personnel, Maintains accurate record of approved, quarantined, rejected products.
• Ensure compliance to all SOPs and other regulatory requirements (e.g. FDA, EPA, OSHA, ISO 13485:2003).
• Review and release final product and maintain authorized person (AP) status; also reviews release and compliance of bulk and intermediates where applicable.
• Conduct audits and inspections; also prepare draft responses to audits and inspections
• Oversee/coordinate drug stability program.
• Oversee process validation lifecycle program.
• Oversee document control program.
• Maintains working knowledge of QA inspection requirements for components, raw materials, in-process/bulk and finished goods.
• Ensures that review of...

CSBio is a fast-paced peptide CMO founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, we opened our peptide production facility in Menlo Park, CA and in 2014, we expanded our production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, we passed a FDA inspection for commercial drug substance manufacturing. In 2019, we expanded into Milpitas, CA for non-clinical production and in 2022, completed our cGMP patient specific cancer vaccine peptide production facility.

We are seeking a qualified individual to join us as the Manager of Quality Assurance at our Menlo Park facility. This position reports to the Direct of Operations. Job...

Simple Mills is a rapidly-growing company on the forefront of the clean food movement, transforming center store grocery aisles with products made from nutritious, purposeful ingredients. Simple Mills is a female-founded business, started by Katlin Smith in 2012 out of her own Kitchen. In the company’s short history, Simple Mills has disrupted the market to become the #1 bestselling natural baking mix, the #1 bestselling natural cracker, and the #1 bestselling natural cookie.

The company’s mission is to advance the holistic health of the planet and its people by positively impacting the way food is made. Simple Mills is distributed in 25,000+ stores nationally including Whole Foods, Target, Walmart, Kroger, Costco and more, and available...

We are seeking an experienced Senior Manager of CMC Quality Assurance to spearhead the quality assurance initiatives for our pioneering curative stem-cell therapies. This role involves establishing and refining the quality assurance processes for the development of HSPC based, HDR (homology directed repair) therapies.

What You Will Do:

• Lead cGMP quality assurance activities for all relevant manufacturing operations, including product disposition via batch record and certificate of analysis (COA) review, in collaboration with our Contract Manufacturing Organization (CMO).
• Develop, implement and manage a comprehensive electronic Quality Management System (eQMS) to support pre-clinical and clinical manufacturing and clinical operations, including development, review and approval of internal documentation, such as Standard Operating Procedures (SOPs) and methods.
• Support development and implementation of Clinical Affairs...

Join us as the Senior Manager/Associate Director of Quality Assurance at Frontier, where precision meets purpose. In this pivotal role, you'll oversee GCP/GLP Quality Assurance activities, ensuring meticulous adherence to standards that drive our growth objectives forward. Beyond external engagements, you'll be a key collaborator, bridging departments to fortify our operational integrity. Your focus on developing our QA infrastructure will be instrumental in realizing our strategic initiatives. If you're ready to bring your analytical prowess to the table, join us and report directly to the head of RA/QA as we navigate the complexities of quality assurance with precision and purpose.

Requirements

What will you be doing?

• Development, implementation, maintenance of quality assurance infrastructure & programs; including establishing quality standards/metrics/objectives, developing methods to embed quality into the...

Simple Mills is a rapidly-growing company on the forefront of the clean food movement, transforming center store grocery aisles with products made from nutritious, purposeful ingredients. Simple Mills is a female-founded business, started by Katlin Smith in 2012 out of her own Kitchen. In the company’s short history, Simple Mills has disrupted the market to become the #1 bestselling natural baking mix, the #1 bestselling natural cracker, and the #1 bestselling natural cookie.

The company’s mission is to advance the holistic health of the planet and its people by positively impacting the way food is made. Simple Mills is distributed in 25,000+ stores nationally including Whole Foods, Target, Walmart, Kroger, Costco and more, and available...