Established in 2002, Nutrabolt is a global nutritional life sciences company that specializes in sports nutrition. Distributed around the world in over 100 countries, the company’s marquee brands, Cellucor and Xtend have become uncontested category leaders in pre-workout and intra/post-workout recovery supplementation respectively. We owe our success to our innovative products, our incredible customers and our commitment to our people.
Reporting to the Director of Quality, the Quality Assurance Manager will be responsible for overseeing compliance in the area of finished product disposition, training, stability studies, finished product specification and label review, as well as product complaint and CAPA investigations using the Product Quality Module (PQM) of Ensur. The Quality Assurance Manager will have a strong understanding of cGMP compliance regulations and experience with Part 110, 111 and 117 of Title 21 including FMSA.
Day in the Life of:
- You will assist management with approval or rejection of finished goods work orders.
- You will review of documentation – test results for raw materials, components and QA inspection documentation to assure material meets specifications.
- You will review and approval of Master Manufacturing Records (MMRs), Production Batch Records (PBRs), Reprocessing Approvals, Planned Deviations, Document Change Requests, Change Control Requests, LIMS templates.
- You will determine disposition of finished goods and release or reject as appropriate.
- You will conduct and/or assist in investigations concerning operational problems, production errors, and/or problems involving customer complaints, and ensures required material reviews and disposition decisions are properly conducted.
- You will ensure representative samples of all in-process materials, labeling, packaging, and finished products are collected, tested, and held.
- You will oversee the maintenance of the retain sample program
- You will identify outstanding issues, establish priorities and timeline for addressing based upon compliance risk and operational needs
- You will perform investigations of customer complaints to determine root cause and identify corrective actions; assist in implementing corrective or preventative actions (CAPA) to ensure product quality. These investigations will include, but are not limited to manufacturing/packaging batch record review and inspection of retain samples.
- You will help develop and implement Process Monitoring Systems by identifying critical process steps which could culminate in possible sources of manufacturing defects and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.
- You will perform trend analysis and report analysis to management as appropriate.
- You will gather data on performance metrics to facilitate the review of program/product effectiveness, efficacy, and actions for adherence to quality.
- Under direction of the Quality Director, you may perform or oversee the completion of certain job functions required by a certified Preventive Control Qualified Individual (PQCI).
- You will lead background audit support to include documentation management, review, and submission, and coordination of subject matter experts, as appropriate.
- You will implement and lead continuous improvement plans for quality functions
- You will develop and maintain QMS including identification and monitoring of KPIs
- You will formulate and administer policies/SOPs relating to quality assurance/control and overall QMS
- You will review and approve deviation reports, ensuring that procedures are followed for documenting and investigating deviations to determine root cause and successful implementation effective CAPA
- You will oversee the Document Change Control Program.
- You will review and approve Change Controls for applicable processes, ensuring that procedures are followed and changes are documented, approved and assessed appropriately.
- You will manage, review and approve QA/QC specifications for all finished goods and raw materials/components as provided by Product Development
- You will participate in projects as assigned, acting as contact with other departments and communicating regularly with direct management regarding status and timeline
- You will be responsible for activation and coordination of product recalls and performing mock recalls annually
- You will assist with staff training and development
- You will provide customer service and training to all employees
- You will interact effectively with co-workers, management and vendors in order to resolve problems
- You will perform all responsibilities in accordance with company guidelines and Standard Operating Procedures (SOPs) and appropriate industry and regulatory standards, guidelines, rules, and regulations
- You will ensure ongoing and timely support of project-related activities and tasks
Our Ideal Candidate:
- Has a degree in a scientific discipline (Chemistry, Engineering, Physics, Biology)
- Has a minimum of 5 years industry experience in cGMP environment, including a leadership role in QA/QC or compliance
- Has exposure to domestic and international regulatory agencies
- Has robust knowledge of Title 21 of the Code of Federal Regulations including experience with Part 110, 111 and 117 of Title 21 including FMSA
- ASQ Quality Engineer Certification, PCQI or HACCP certification preferred
- Has excellent written and verbal communication skills
- Has superior attention to detail and excellent investigation, problem solving and organizational skills
- Is able to work effectively with people and communicate information to obtain positive results
- Is capable of taking direction and completing assigned tasks on time
- Is independent and able to manage time efficiently and adjust to shifting priorities quickly
- Can work well with a diverse group of people and be a strong and dependable team player
- Must be able to work well under tight deadlines
- We offer unlimited vacation time, to promote work life balance and show our appreciation for our employee’s hard work.
- We encourage and support our employees active participation in giving back to the community by providing paid volunteer time off.
- We celebrate families through our paid maternity or paternity leave.
- We help support our employee’s fitness journeys by providing a gym allowance.
- We provide our employees with a monthly product allowance to stock up on Cellucor and Xtend products and swag.
- We are committed to our employee’s continued personal and professional development. To help support individual and team growth, we offer a fully paid LinkedIn Learning membership as well as other development tools.
- We give our employees the fuel they need to perform with access our fully stocked Cellucor and Xtend product bar and company provided meals.
- We invest in our employee’s future though 401K matching.
- We offer our employees competitive health/dental/vision insurance including options such as HSA and flexible spending accounts.