Senior Assurance

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...

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...

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...

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Primary Requirements: Please Review Before Applying!

In an effort to respect and value your time, we’ve positioned our primary requirements at the beginning. We urge you to review them thoroughly to ensure a mutual fit before applying.

• Must reside in the Atlanta, GA, metro area while working
• This role is W-2-only and it is a long-term contract opportunity (no C2C)
• We are unable to offer sponsorship for this role
• Standard Eastern Time business hours (full-time)
• This is a hybrid role requiring 2-3 days/week on site in the north-west Atlanta Metro area
  

Please Note: If you do not meet the requirements for this role but wish to be considered for other positions, please check our current...

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...

The Software QA Analyst has the drive to succeed with hard work and is able to "think outside the box," attempting to simulate user behavior that software developers did not anticipate. Willing to maintain a flexible schedule and perform certain duties after hours when required to limit disruption of services. Ideal candidate must be able to work in a fast paced environment while juggling many tasks, changing priorities and staying up to date with the latest technologies.

Must have the below:

Salesforce

Manual testing

SQL

Automated Testing

Healthcare / Pharmacy

API testing

Responsibilities:

• Develops comprehensive test conditions and test cases for complex information systems and/or software programs. Performs test execution to ensure proper operation of system/program
• Participates in all aspects of functional testing
• Evaluates and documents complex test results.
...

Title: Risk Assurance Manager / Senior

Location: San Francisco, CA / Portland, OR

Type: Full-time

No. of Roles: 3 (1 Senior / 2 Manager)

Requirements

Minimum Qualifications

• Bachelor's degree in accounting or related field required; Master’s degree preferred
• 2+ OR 4+ years of experience in external or internal audit, internal control testing and documentation, internal control assessments, and report writing required
• Previous experience in auditing or reviewing quarterly financial reports, analyzing business risks, implementing new compliance standards and risk assessments required
• Previous experience in a public accounting firm required
• Recent Internal Audit and SOX 404 compliance experience required
• CPA, CIA, and/or CISA required
• Previous experience handling multiple engagements simultaneously, while...