Sr. Quality Assurance Associate (Stability/Complaints)
About You
As a Sr. Quality Assurance Associate, you will be responsible for executing day-to-day quality assurance activities, to ensure dietary supplement QA GMP compliance in an exciting, growing company. You will bring expertise and experience in the dietary supplement category and have strong knowledge and experience in executing QA GMP processes and procedures. Your knowledge and experience will enable Nutrafol to continue to grow as a competitive and agile business, enabling speed to market and competitive product claims, within global regulated industry segments. In this role, you will report to the Sr. Director of Quality Assurance and will be responsible for executing end-to-end QA support that will help grow and protect the business.
Responsibilities:
Managing the Stability Program:
Writing real-time and accelerated stability protocols and reports for new and existing dietary supplement and cosmetic products
Coordinating stability samples with manufacturers and external laboratories
Logging and reviewing results, performing trending and analysis of those results
Creation and maintenance of the annual stability schedule
Investigating out of specification test results and recommend corrective actions
Supporting the Product Quality Complaint Program
Reviewing product quality complaints
Creating investigation summaries for product complaints
Trending data and creating monthly and quarterly reports
Identifying CAPAs as applicable based on investigations and/or trends
Working with Customer Service and Suppliers as required
Supporting other quality programs as needed such as artwork review, change control, product release, deviation/ out of specification program and other projects as assigned
Partner with external stakeholders, such as manufacturers and testing laboratories, and internal partners such as Formulation, Product Development, Supply Chain, and RA, to ensure timely QA deliverables, working as an effective member of cross-functional product teams
Requirements:
Bachelor’s degree in quality assurance, biology, chemistry, medical sciences, pharmacology etc.; or an equivalent combination of education and experience sufficient to successfully perform the key accountabilities of the job
5+ years of direct US dietary supplement/Consumer Healthcare Quality experience
Knowledge of product stability programs and laboratory testing preferred
Knowledge and experience on FDA and applicable laws and regulations, as well as of cGMP standards
Hands-on experience executing QA GMP compliance for a broad portfolio of dietary supplements or related products
Applied technical knowledge to ensure GMP standards are met throughout the product life cycle
Effective prioritization skills and the ability to execute on multiple projects, collaboratively and independently, in an agile environment
Proven ability to communicate and collaborate effectively with a variety of audiences, both internal and external.
Strong analytical, organization and critical thinking skills
Preferred:
Dietary Supplement category experience
Nutrafol takes into consideration a wide range of factors in final compensation decisions, including but not limited to: skill sets, experience and training, licensure and certifications, qualifications and education, and other business and organizational needs. The listed range is applicable only to the annual base salary and does not include additional perks, benefits, or applicable bonus eligibility comprising the total compensation package.
Salary Range:
$85,000—$100,000 USD
Sr. Quality Assurance Associate (Stability/Complaints)
About You
As a Sr. Quality Assurance Associate, you will be responsible for executing day-to-day quality assurance activities, to ensure dietary supplement QA GMP compliance in an exciting, growing company. You will bring expertise and experience in the dietary supplement category and have strong knowledge and experience in executing QA GMP processes and procedures. Your knowledge and experience will enable Nutrafol to continue to grow as a competitive and agile business, enabling speed to market and competitive product claims, within global regulated industry segments. In this role, you will report to the Sr. Director of Quality Assurance and will be responsible for executing end-to-end QA support that will help grow and protect the business.
Responsibilities:
Managing the Stability Program:
Writing real-time and accelerated stability protocols and reports for new and existing dietary supplement and cosmetic products
Coordinating stability samples with manufacturers and external laboratories
Logging and reviewing results, performing trending and analysis of those results
Creation and maintenance of the annual stability schedule
Investigating out of specification test results and recommend corrective actions
Supporting the Product Quality Complaint Program
Reviewing product quality complaints
Creating investigation summaries for product complaints
Trending data and creating monthly and quarterly reports
Identifying CAPAs as applicable based on investigations and/or trends
Working with Customer Service and Suppliers as required
Supporting other quality programs as needed such as artwork review, change control, product release, deviation/ out of specification program and other projects as assigned
Partner with external stakeholders, such as manufacturers and testing laboratories, and internal partners such as Formulation, Product Development, Supply Chain, and RA, to ensure timely QA deliverables, working as an effective member of cross-functional product teams
Requirements:
Bachelor’s degree in quality assurance, biology, chemistry, medical sciences, pharmacology etc.; or an equivalent combination of education and experience sufficient to successfully perform the key accountabilities of the job
5+ years of direct US dietary supplement/Consumer Healthcare Quality experience
Knowledge of product stability programs and laboratory testing preferred
Knowledge and experience on FDA and applicable laws and regulations, as well as of cGMP standards
Hands-on experience executing QA GMP compliance for a broad portfolio of dietary supplements or related products
Applied technical knowledge to ensure GMP standards are met throughout the product life cycle
Effective prioritization skills and the ability to execute on multiple projects, collaboratively and independently, in an agile environment
Proven ability to communicate and collaborate effectively with a variety of audiences, both internal and external.
Strong analytical, organization and critical thinking skills
Preferred:
Dietary Supplement category experience
Nutrafol takes into consideration a wide range of factors in final compensation decisions, including but not limited to: skill sets, experience and training, licensure and certifications, qualifications and education, and other business and organizational needs. The listed range is applicable only to the annual base salary and does not include additional perks, benefits, or applicable bonus eligibility comprising the total compensation package.
Salary Range:
$85,000—$100,000 USD