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Senior Quality Specialist

Nestle
United States, Massachusetts, Waltham
Sep 12, 2024

At Nestle Health Science, we believe that nutrition, science, and wellness must merge, not collide. Here, we embrace the intrinsic connections of these three pillars, harnessing their collective strength to empower healthier lives. Our broad product portfolio includes renowned brands like Garden of Life, Nature's Bounty, Vital Proteins, Orgain, Nuun, BOOST, Carnation Breakfast Essentials, Peptamen, Compleat Organic Blends, and more. We also have extensive pharmaceutical expertise, offering innovative medicines that aim to prevent, manage, and treat gastrointestinal and metabolic-related diseases.

At Nestle Health Science, we bring our best for better lives. Our people are challenged to bring fresh, diverse views and make bold moves to empower healthier lives through nutrition. We know brilliant ideas can come from anyone, anywhere. Here we embrace the entrepreneurial spirit and collaborate with teams that champion focused and forward thinking. We are committed to fostering professional growth and celebrating the achievements of our people along the way. We offer dynamic career paths, robust development, opportunities to learn from talented colleagues around the globe, and benefits that support physical, financial, and emotional wellbeing.

Join us to innovate for impact and reimagine the future of health and nutrition for patients and consumers.

Position Summary:
Reporting to the Director, QA Donor Operations, the Principal Associate, Donor Operations Quality Assurance will work closely with our operational teams to support the collection of donor derived products. You will be involved in the quality support of collection facility personnel as well as engaged in the review of batch records to ensure the appropriate release of donor material to serve at risk populations. Please note this role is an on-site position.

This is an exciting opportunity for anyone who excels at active, and creative problem solving. While this is a GMP environment, it is not your typical experience, our program requiring a unique opportunity to apply GMP principles to an area as yet unregulated by the FDA. Our unique product provides the opportunity to grow within a cutting edge GMP program, setting the benchmark for a new industry.

This role requires not only a strong application of GMP principles, but curiosity and attention to details in a fast-paced environment. You will have the opportunity to be a key contributor to the program as well as grow with the organization as it brings a pioneering product to the market. Due to the unique nature of our product, this is not a cookie cutter assembly of requirements, and requires an excitement and attention to detail to understand the unique biology of our product, and the controls necessary to support it. If you're excited about the opportunity to learn and apply quality controls to a new product, and to grow with our organization, this may be the right place for you.

Key Responsibilities:
* Provides quality guidance, support and reviews for a Donation Collection Facility and Donation Operation's projects and programs, ensuring follow up activities are completed and in compliance with requirements.
* Perform detailed batch record reviews and participate in Donor Review Committees.
* Perform initiation, investigation, and corrective action monitoring for deviations and CAPAs related to donation collection facilities or other assigned Donor Program areas.
* Perform record retention and archival tasks, including but not limited to deviations, CAPAs, change control documents, batch records and logbooks.
* May participate in development, review and training of Donor Program processes/procedures.
* Other duties as assigned including providing support to other Seres quality groups as needed.
* Occasional travel may be required to Donation Collection Facilities.

Experience and Education Requirements:
* 8+ years of quality experience, and a Science or Engineering degree.
* Experience in batch records or GMP auditing is required, as well as in investigation and corrective action assessment for deviations and CAPAs.
* Strong verbal and written communication are essential, as well as strong interpersonal skills as we work across department lines to ensure we can support donation activities, and the needs of Seres Therapeutics overall.
* ASQ Certified Quality Auditor (CQA), or equivalent, a plus.

Requisition ID:319103

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 Nestle. 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. Nestle seeks such skilled and qualified individuals to share our mission where you'll join a cohort of others who have chosen to call Nestle home.

The Nestle 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.

Review our applicant privacy notice before applying at https://www.nestlejobs.com/privacy

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