Life Sciences Manufacturing Quality Assurance Consultant

We are:

Industry X.0, the speed2value visionaries who roll up our sleeves in multi-disciplinary creative teams. We collaborate obsessively to deliver the highest quality value at lightning speed — we work fast, we work hard, and we work smart. Whether we’re racing ahead of the market on 3D printing technologies, AR/VR and wearables, coding on IoT products, or developing next-level robotics, we build the right product, make ambitious discoveries, and set the pace for what’s next. Join us as we reinvent industries such as Retail Products, Medical Tech Equipment, Media, High Tech, Aerospace and Defense, Chemicals, Mining, Oil and Gas, and Utilities. Visit us here to find out more about Industry X.0  

You are:

A ambitious Manufacturing Systems (MES) Associate Manager ready to take on new challenges. As industries head towards Manufacturing and Factory Digitalization, MES stand in the center of manufacturing excellence.

The Work:

• Need experience with biological and chemical manufacturing operations to produce therapeutics including cell culture, fermentation, harvest, purification, chemical synthesis, solid dosage form, formulation, liquid filling, lyophilization, packaging, and final product serialization
• Must be an expert on what is required to be captured in a batch record based on international regulations
• Assess MES related CAPAs and inspection commitments
• Change control QA contact role
• Provide guidance on global SOP content and approve documents
• Work with MBR designer and process engineer to develop and approve batch records
• Assess site QA SOPs for need to change
• Provide guidance on SOP content
• Provide Quality input to MES related standards/guidelines
• Approve site batch record objects
• Serve as QA approver for legacy site documentation removal and revision of impacted documents
• Provide Quality SME input for new Quality related training materials

Please note that this role is only for NA.

Here's What You Need:

• Minimum of 3 years of experience with life sciences manufacturing solutions
• Knowledge of FDA and GMP guidelines
• Bachelor’s Degree or equivalent (minimum 3 years work experience). If Associate’s Degree, must have equivalent minimum 6 years work experience

Set Yourself Apart:

• Strong written and oral communication skills
• Ability to work in a team-oriented, collaborative environment
• Ability to facilitate meetings and follow up with resulting action items
• Understanding of Life Sciences validation processes

As required by the Colorado Equal Pay Transparency Act, Accenture provides a reasonable range of minimum compensation for roles that may be hired in Colorado. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For the state of Colorado only, the range of starting pay for this role is $62,640 - $143,900  and information on benefits offered is here. 

COVID-19 update:

The safety and well-being of our candidates, our people and their families continues to be a top priority. Until travel restrictions change, interviews will continue to be conducted virtually.

Subject to applicable law, please be aware that Accenture requires all employees to be fully vaccinated as a condition of employment. Accenture will consider requests for accommodation to this vaccination requirement during the recruiting process.

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