Quality Assurance Specialist

Bloom Nutrition

IG @Bloomsupps @Marillewellyn

TikTok @Bloomnu

Bloomnu.com

About Bloom :

Founded by wellness influencer and entrepreneur Mari Llewellyn, Bloom Nutrition is one of the fastest growing wellness brands in the US. Our mission is to help people bloom into their best selves through nutritious and delicious wellness solutions.

Recognized for our innovation and growth, we're proud recipients of several awards :

Forbes 30 under 30 (2023)

Target Partner of the Year (2023)

LinkedIn's Top Start-Ups (2023 & 2024)

EY Entrepreneurs of the Year (2024)

Inc. 5000 Company (2024)

NewBeauty 100 Wellness Awards (2024)

Job Description

As Bloom’s Quality Assurance Specialist, you will be responsible for the development and organization of Bloom processes and procedures that govern Quality document operations. This includes documentation management in its existing format with the intent to integrate into a QMS to support business growth. This position will be heavily weighted in providing input and supporting processes to streamline the workflow. Process improvements may include Formula build and organization of documents that support the formula including raw material, and packaging specifications and the creation of finished goods specification documents. This position will be responsible for Manufacturer of Record Certification of Analysis review and final disposition of finished goods to ensure procedural and regulatory compliance requirements are met. You will conduct training on quality assurance concepts and tools and will have a strong understanding of cGMP compliance regulations. The Quality Assurance Specialist will provide support to ensure finished product released for distribution meets safety and quality standards and performs tasks as necessary to meet shipment deadlines. The position is responsible for accurate documentation and upholding business procedures to ensure regulatory compliance and company certifications. This position requires a strong knowledge of Quality Assurance concepts and tools and will have a strong understanding of cGMP compliance regulations.

Reports to : Director of Quality Assurance and Regulatory

Direct reports : None

Location

hybrid Austin, Texas or LA required.

Duties and Responsibilities

The Quality Assurance Specialist will support the release and distribution of dietary supplements, by inspecting the product and packaging to ensure conformance to specification. The Quality Assurance Specialist is responsible for understanding and upholding business process flow and regulatory compliance from raw materials and components to finished product and how that impacts internal business operations. In addition, the quality systems, standards, and priorities set by our company, FDA and other regulatory entities must be understood and upheld by the Quality Assurance Specialist. This position reports into the Quality department with direct reporting to the Director of Quality Assurance and Regulatory.

Responsibilities

• Train company personnel on compliance-related topics and procedures
• Review operational and procedural requirement improvement opportunities for Document Control operations
• Manage and review documentation, including, but not limited to test results for raw materials, components, labels, COA / COCs, and QA inspection documentation to assure material meets specifications
• Ability to write and review standard operating procedures (SOPs) and product specifications.
• Review Production Batch Records (PBRs), Reprocessing Approvals, Planned Deviations, Document Change Requests, etc.
• Oversee all QA controlled documentation and reporting including OOS, Complaints, Deviations, CAPAs, etc.
• Oversee all QA finished product release related functions
• Work closely with Supply Chain / Purchasing to facilitate creation / completion of deviation records to support production and / or release of finished product in accordance with Supply Chain schedules
• Communicate quality related issues to Quality Leadership, Operations and suppliers, as necessary.
• Understand requirements needed to support release of first production runs and / or international production (if applicable) for dietary supplements
• Provide support for retailer set-ups and completing questionnaires.
• Ability to review and interpret analytical and microbiological lab reports
• Prepare samples for submission to laboratory for analysis
• Prepare Lab submission forms and track and follow up on lab results based on standard turnaround times
• Process sensory samples for evaluation as needed
• Perform product inspection of finished goods
• Oversee the Company retain program
• Oversee the Company stability program and substantiation of current shelf life
• Ability to review documentation, assess and communicate test results and collaborate with Quality Management on corrective / preventative action(s) (CAPAs)
• Ability to identify trends and provide detailed written observations to management
• Assist with conducting formal procedural inquiries and investigations related to Non-Conformances, Deviations and Customer Complaints to determine the cause of quality problems, recommend verbal and / or written corrective action to management as required
• Ability to provide background audit support to include documentation management, review, and submission, and coordination of subject matter experts
• Ability to manage complex tasks individually or as part of a team to meet departmental and / or company goals
• Perform all responsibilities in accordance with company guidelines and Standard Operating Procedures (SOPs) and appropriate industry and regulatory standards, guidelines, rules, and regulations
• Act as subject matter expert in the interpretation and implementation of all applicable regulatory requirements (e.g., 21 CFR Parts 111, applicable sections of 117 Halal, Kosher, Non-GMO, NSF, LGC.or other applicable certifications)
• Attend first production runs and on-site team meetings as needed
• Perform other job functions as required

QUALIFICATIONS

Benefits :