Product Quality Assurance Coordinator (2nd Shift)

Aimmune Therapeutics

Aimmune Therapeutics

Product, Quality Assurance
San Antonio, TX, USA
Posted on Friday, January 26, 2024

Product Quality Assurance Coordinator (2nd Shift)

Product Quality Assurance Coordinator (2nd Shift)

As a leader in the science of nutrition, Nestlé Health Science believes in empowering healthier lives for patients and consumers through a rich product portfolio featuring top brands such as Garden of Life®, Nature’s Bounty®, Vital Proteins®, Nuun®, Persona Nutrition®, BOOST®, Carnation Breakfast Essentials®, Peptamen®, Compleat Organic Blends®, and more, as well as through Aimmune Therapeutics, a biopharmaceutical company developing therapies to prevent, manage and treat food, GI and metabolic-related diseases.

Our team members are challenged to make a genuine impact and play an integral role in driving the business forward. We embrace a dynamic culture that always puts the consumer first, and where ownership, accountability and agility are celebrated at every level. To help our people thrive, we offer expansive career growth potential, the opportunity to work alongside and learn from talented colleagues with diverse backgrounds and skill sets, and a range of best-in-class benefits.

We have more than 11,000 employees around the world, and products available in over 140 countries.

This position is not eligible for Visa Sponsorship.

Position Summary:

Under the direction of the Quality Manager, the Product Quality Assurance Coordinator is responsible for ensuring products are being produced in a manner that meets all cGMP (Current Good Manufacturing Practice) and Product Specification criteria. This position drives First Pass Quality Indicators and adherence to cGMP's on the production floor at all times. This position supports our 2nd Shift, Monday-Friday 1:30-9:30pm.

Responsibilities:

  • Supports site data management system
  • Leads root cause analyses and basic problem-solving discussions documenting the results in the adequate template, 5 Why, Fishbone, etc.
  • Populates the Quality Dashboard, tracks, and trends site KPI (key performance indicator) data i.e., drying room temperatures, warehouse temperatures, etc.
  • Acts as site Super User for the document management program and can train associates
  • Performs mock recalls and traceability exercises
  • Ensures accurate and timely completion of batch documentation review to ensure real-time compliance to product specifications, good documentation practices, company SOP's (Standard Operating Procedures) and cGMPs
  • Manages batch record scanning and storage program, retrievals for R&D, audit or operations review when required for formula changes, auditor review or operational issues
  • Leads Site Investigator for all customer complaints, completes investigations and reports findings
  • Provides real-time guidance to production associates pertaining to compliance to cGMP
  • Performs daily compliance audits and signs off on responsible areas within production
  • Manages the warehouse temperature monitoring program
  • Schedules site calibrations for all production and warehouse scales and equipment using load cells
  • Leads the back room and document retrieval for all third-party audits for FDA, UL, USP, State of Texas, GFCO, Internal audits, etc.
  • Assists with management of site SOP curriculum and training matrix with the site training coordinator
  • Manages the environmental monitoring program
  • Responsible for bulk Sensory Evaluation and release and Physical testing for raw materials

Qualifications:

  • 3+ years’ experience in a manufacturing or production environment
  • High School Diploma or GED
  • Intermediate knowledge of PC programs, i.e., MS Office (Excel, Word, and PowerPoint)
  • Nice to have : advanced degree, quality assurance training, experience with SAP (Enterprise Resource Planning software)

Skills:

  • Strong verbal and technical writing skills
  • Basic knowledge in mathematics and solving basic algebraic equations
  • Working knowledge of cGMP guidelines is preferred
  • Working knowledge of database work sheets (Access, etc.)
  • Ability to work collaboratively within teams in a high-performance environment
  • Ability to maintain effectiveness during major changes in work tasks or the work environment, adjusting effectively to within new work structures, processes, requirements, or cultures
  • Continuously looks for ways to do things faster and better, while maintaining high quality standards
  • Creative and curious; tries different and novel ways to solve obstacles

Requistion ID#

270235

It is our business imperative to remain a very inclusive workplace.

To our veterans and separated service members, you're at the forefront of our minds as we recruit top talent to join Nestlé. The skills you've gained while serving our country, such as flexibility, agility, and leadership, are much like the skills that will make you successful in this role. In addition, with our commitment to an inclusive work environment, we recognize the exceptional engagement and innovation displayed by individuals with disabilities. Nestlé seeks such skilled and qualified individuals to share our mission where you’ll join a cohort of others who have chosen to call Nestlé home.

The Nestlé Companies are an equal employment opportunity and affirmative action employer seeking diversity in qualified applicants for employment. All applicants will receive consideration for employment without regard to race, ethnicity, color, gender, gender identity, age, religion, national origin, ancestry, disability, perceived disability, medical condition, genetic information, veteran status, sexual orientation, or any other protected status, as defined by applicable law. Prior to the next step in the recruiting process, we welcome you to inform us confidentially if you may require any special accommodations in order to participate fully in our recruitment experience. Contact us at accommodations@nestle.com or please dial 711 and provide this number to the operator: 1-800-321-6467.

This position is not eligible for Visa Sponsorship.

As a leader in the science of nutrition, Nestlé Health Science believes in empowering healthier lives for patients and consumers through a rich product portfolio featuring top brands such as Garden of Life®, Nature’s Bounty®, Vital Proteins®, Nuun®, Persona Nutrition®, BOOST®, Carnation Breakfast Essentials®, Peptamen®, Compleat Organic Blends®, and more, as well as through Aimmune Therapeutics, a biopharmaceutical company developing therapies to prevent, manage and treat food, GI and metabolic-related diseases.

Our team members are challenged to make a genuine impact and play an integral role in driving the business forward. We embrace a dynamic culture that always puts the consumer first, and where ownership, accountability and agility are celebrated at every level. To help our people thrive, we offer expansive career growth potential, the opportunity to work alongside and learn from talented colleagues with diverse backgrounds and skill sets, and a range of best-in-class benefits.

We have more than 11,000 employees around the world, and products available in over 140 countries.

This position is not eligible for Visa Sponsorship.

Position Summary:

Under the direction of the Quality Manager, the Product Quality Assurance Coordinator is responsible for ensuring products are being produced in a manner that meets all cGMP (Current Good Manufacturing Practice) and Product Specification criteria. This position drives First Pass Quality Indicators and adherence to cGMP's on the production floor at all times. This position supports our 2nd Shift, Monday-Friday 1:30-9:30pm.

Responsibilities:

  • Supports site data management system
  • Leads root cause analyses and basic problem-solving discussions documenting the results in the adequate template, 5 Why, Fishbone, etc.
  • Populates the Quality Dashboard, tracks, and trends site KPI (key performance indicator) data i.e., drying room temperatures, warehouse temperatures, etc.
  • Acts as site Super User for the document management program and can train associates
  • Performs mock recalls and traceability exercises
  • Ensures accurate and timely completion of batch documentation review to ensure real-time compliance to product specifications, good documentation practices, company SOP's (Standard Operating Procedures) and cGMPs
  • Manages batch record scanning and storage program, retrievals for R&D, audit or operations review when required for formula changes, auditor review or operational issues
  • Leads Site Investigator for all customer complaints, completes investigations and reports findings
  • Provides real-time guidance to production associates pertaining to compliance to cGMP
  • Performs daily compliance audits and signs off on responsible areas within production
  • Manages the warehouse temperature monitoring program
  • Schedules site calibrations for all production and warehouse scales and equipment using load cells
  • Leads the back room and document retrieval for all third-party audits for FDA, UL, USP, State of Texas, GFCO, Internal audits, etc.
  • Assists with management of site SOP curriculum and training matrix with the site training coordinator
  • Manages the environmental monitoring program
  • Responsible for bulk Sensory Evaluation and release and Physical testing for raw materials

Qualifications:

  • 3+ years’ experience in a manufacturing or production environment
  • High School Diploma or GED
  • Intermediate knowledge of PC programs, i.e., MS Office (Excel, Word, and PowerPoint)
  • Nice to have : advanced degree, quality assurance training, experience with SAP (Enterprise Resource Planning software)

Skills:

  • Strong verbal and technical writing skills
  • Basic knowledge in mathematics and solving basic algebraic equations
  • Working knowledge of cGMP guidelines is preferred
  • Working knowledge of database work sheets (Access, etc.)
  • Ability to work collaboratively within teams in a high-performance environment
  • Ability to maintain effectiveness during major changes in work tasks or the work environment, adjusting effectively to within new work structures, processes, requirements, or cultures
  • Continuously looks for ways to do things faster and better, while maintaining high quality standards
  • Creative and curious; tries different and novel ways to solve obstacles

Requistion ID#

270235

It is our business imperative to remain a very inclusive workplace.

To our veterans and separated service members, you're at the forefront of our minds as we recruit top talent to join Nestlé. The skills you've gained while serving our country, such as flexibility, agility, and leadership, are much like the skills that will make you successful in this role. In addition, with our commitment to an inclusive work environment, we recognize the exceptional engagement and innovation displayed by individuals with disabilities. Nestlé seeks such skilled and qualified individuals to share our mission where you’ll join a cohort of others who have chosen to call Nestlé home.

The Nestlé Companies are an equal employment opportunity and affirmative action employer seeking diversity in qualified applicants for employment. All applicants will receive consideration for employment without regard to race, ethnicity, color, gender, gender identity, age, religion, national origin, ancestry, disability, perceived disability, medical condition, genetic information, veteran status, sexual orientation, or any other protected status, as defined by applicable law. Prior to the next step in the recruiting process, we welcome you to inform us confidentially if you may require any special accommodations in order to participate fully in our recruitment experience. Contact us at accommodations@nestle.com or please dial 711 and provide this number to the operator: 1-800-321-6467.

This position is not eligible for Visa Sponsorship.

San Antonio, TX, US, 78219

San Antonio, TX, US, 78219


Nearest Major Market: San Antonio