Who You Are:Reporting to the Manager, Quality Innovation and Technical Services, the Technical Analyst - Quality is responsible for developing, implementing, and managing quality programs and performance metrics that drive continuous improvement initiatives across the organization. The Quality Technical Analyst assists in the quality investigations involving out-of-specification (OOS) results, conducts root cause analyses, and manages corrective and preventive action (CAPA) programs to ensure timely and effective resolution of quality issues.
The Technical Analyst - Quality develops and deploys quality strategies, policies, and procedures to ensure products consistently meet or exceed company, customer, and regulatory requirements. Leveraging expertise in chemistry, microbiology, manufacturing processes, analytical testing methodologies, and laboratory equipment, this position supports product quality, regulatory compliance, and operational excellence.
Key responsibilities include overseeing the development, review, and maintenance of raw material and finished product specifications; ensuring appropriate chemical, analytical, and microbiological testing requirements are established; and verifying that testing methods, equipment, and frequencies align with industry standards and regulatory expectations. The role also ensures compliance with FDA regulations, including 21 CFR Parts 111 and 117, and collaborates cross-functionally with internal teams, suppliers, and external partners to resolve quality issues and support continuous improvement efforts.
What You're Good At:- Support the Manager in the execution and tracking of internal and external CAPA programs related to product formulations, deviations, nonconformances, customer complaints, and out-of-specification (OOS) results ensuring timely implementation, tracking, and verification of corrective and preventive actions.
- Conduct quality investigations, perform root cause analyses, evaluate quality events, and support timely resolution of issues to facilitate product release and regulatory compliance.
- Collect, review, and organize supporting data required for investigations and product release decisions.
- Analyze, trend, and interpret analytical, microbiological, and quality testing data to identify risks, investigate adverse trends, and recommend corrective actions and process improvements.
- Monitor CAPA effectiveness and maintain records to ensure timely closure and compliance requirements.
- Prepare investigation summaries, technical reports, and documentation packages for management review
- Develop, implement, and lead continuous improvement initiatives that enhance Quality processes, systems, compliance, and operational performance.
- Support the development, review, approval, and maintenance of raw material, component, packaging, and finished product specifications using risk-based quality principles.
- Monitor, trend, analyze, and interpret analytical testing data for raw materials and finished products to identify quality risks, opportunities for improvement, and emerging trends.
- Coordinate and support product stability programs, including protocol development, sample management, data review, reporting, and evaluation of product performance and shelf-life trends.
- Identify quality, compliance, and operational risks; establish priorities and action plans; and manage timelines to ensure effective resolution.
- Develop, track, and report quality performance metrics, dashboards, and key performance indicators (KPIs) to monitor program effectiveness and support management decision-making.
- Prepare quality summaries, trend analyses, technical reports, presentations, and management review materials to communicate quality performance and improvement opportunities.
- Serve as a quality representative on cross-functional projects, ensuring effective communication of project status, milestones, risks, and timelines to management and stakeholders.
What You Contribute:- Bachelor's degree in Chemistry, Biochemistry, Microbiology, Biology, Pharmaceutical Sciences, or a related scientific discipline.
- Minimum 5 years of experience in a Quality Assurance, Quality Control, Laboratory, Technical Services, Product Quality, or Compliance role within a cGMP-regulated environment.
- Robust working knowledge of Title 21 of the Code of Federal Regulations including 21 CFR Parts 111 and 117 and FMSA
- ASQ (i.e. CQA, CHA, CQI, CQE, CQM), PCQI, or HARPC certification preferred
- Strong analytical, problem-solving, technical writing, and data analysis skills.
- Basic statistics Average, Standard Deviation, Relative Standard Deviation and ANOVA
- Proficiency in Microsoft Office applications and quality data analysis/reporting tools.
- Excellent communication and interpersonal skills with the ability to work effectively across departments and external partners.
- Independent, and able to manage multiple priorities and work independently in a fast-paced environment.
- Familiar with lab environment and using pH meters, scales, and other lab equipment.
In this position, your goals and KPI's will be focused on:- Earning Trust
- Sound Judgement
- Customers First
- Taking Ownership
- Relentlessly Pursuing Improvement
Why Nutrabolt?Wellness Benefits
Nutrabolt cares about our teammates' physical, mental, and financial wellness by providing benefits like: competitive health insurance, life insurance, mental wellness programs, 401K matching, and a Lifestyle Spending Account.
Lifestyle Perks
We offer unlimited vacation paid time off and volunteer time off. You'll get discounts on C4 Energy, Cellucor, and XTEND products, too!
Family Support
We want you to reach your full potential at work by taking care of all loved ones at home. We provide paid parental leave, in addition to reimbursement for expenses related to childcare, fertility treatments, legal fees, and more through our Lifestyle Spending Account.