Manager, Quality

About 10x:

10x Labs is a nutraceutical manufacturing company located in Plano, Texas. 10x Labs provides high quality dietary supplement manufacturing without compromise. Offering the ultimate in fast, clean, efficient, cGMP contract manufacturing, we proudly provide competitive pricing, superior customer service, quick turn-around times, concise communication, and third-party logistics solutions. At 10x Labs, our customers are always first. Utilizing our in-house lab, top-of-the-line machinery, and experienced formulators, 10x Labs is capable of quickly, efficiently, and accurately solving our customers’ needs. For more than 15 years, we have been in the ecommerce space selling products direct to consumers. 10X Systems is the result of those incredible successes and epic failures—a full suite of stress-free “Scaling as a Service” solutions that include manufacturing & product sourcing, fulfillment, inbound/outbound call center, CFO services, fraud prevention and chargeback management, growth funding, and a go-to network of contacts and resources—all in ONE place to help you scale your business quickly and effortlessly.

JOB SUMMARY

The Quality Manager is responsible for developing and implementing a comprehensive quality management system to ensure the highest level of product and process quality across our organization. The key responsibilities will be to ensure that all prescribed processes are defined and followed, all required documentation is completed accurately and timely, and all customer-specific and regulatory compliance requirements are met. The Quality Manager will also work closely with other department heads to identify areas for improvement, implement quality control measures, and drive continuous improvement initiatives.

PRIMARY DUTIES AND RESPONSIBILITIES

The list below is intended to capture the most essential duties and responsibilities of the job. The list is not exhaustive, and other duties may be assigned at any time:

• Develop & Implement 10X-Labs Quality Control/Quality Assurance Program:

o Develop and implement a robust quality management system to ensure compliance with industry standards and regulations.

o Establish and monitor key quality performance indicators (KPIs) to assess the effectiveness of quality control processes. Develop and deliver training programs to enhance the quality awareness and skills of employees.

o Review Certificates of Analysis from suppliers and coordinate testing for efficacies of herbs, vitamins, minerals etc. to sustain label claim.

o Ensure that testing standards, procedures, and equipment provide reliable results and prevent shipment of defective products.

o Provide leadership to ensure successful product launches, by ensuring clear specification development, process capability definition, and attainment of customer satisfaction on initial shipments.

o Perform assessments of process quality parameters, food safety systems, hygiene, housekeeping, and sanitation support.

o Monitor customer feedback and implement measures to address customer concerns and improve satisfaction.

• Auditing and Documentation:

o Perform pro-active quality reviews with Production and Quality teams.

o Document all quality inspections.

o Provide support for projects as requested.

o Review batch records, test results, and monitor customer feedback.

o Interpret project details and specifications.

o Oversee and assist in the management of mitigating and resolving potential claims.

o Drive MRB, Corrective/Preventive Actions, Deviations, COPQ, and QMS Auditing.

o Conduct regular and recurring management reviews with leadership reporting on the state of the QMS.

• Monitor and Enforce 10X-Labs’s Quality Control/Quality Assurance Program:

o Ensure compliance and responsiveness is met with all regulatory agencies.

o Supervise and mentor QA personnel on the Quality Management Systems including all required inspection and testing requirements.

o Coordinate closely with leadership to ensure that all required Quality Control Programs are properly implemented and executed.

o Monitor QC/QA results and provide immediate attention when there are issues.

o Audit QC/QA plan and enforce work plans and procedures.

o Research corrective measures when necessary and recommend action.

o Prepare and present reports on quality performance, trends, and improvement initiatives to leadership.

• Troubleshooting and Problem Solving:

o Lead root cause analysis and corrective action processes to address quality issues and drive continuous improvement.

o Utilize tools such as 5why, Cause-Effect, Six Sigma (DMAIC), or 8D.

o Develop, maintain, and communicate policies, procedures, and processes that help prevent problems from occurring.

o Evaluate all solutions for Quality and Cost impact.

o Inform all necessary personnel of the overall impact of the problem and ensure the proper communication and execution takes place through resolution.

o Train others to develop more advanced skills in effective troubleshooting.

o Studies problems and recommends solutions.

• Risk Management:

o Identify, assess, and document project risks and develop mitigation strategies.

o Monitor and report on identified risks, ensuring appropriate actions are taken to minimize their impact.

o Support the implementation of risk management processes and tools.

• Relationships:

o Participate in networking events and business development opportunities within Industry and Professional organizations and associations.

o Maintain positive, productive relationships with ALL stakeholders, including 10X-Labs employees, Subcontractors, Vendors, Owners, and regulatory entities.

o Always represents 10X-Labs with the highest standard of professionalism – Lead by example.

• Miscellaneous Duties:

o Receive Supervisory guidance with respect to overall objectives; operate within department policy guidelines using independent judgment in achieving assigned objectives and perform additional assignments per supervisor’s direction.

o Stay updated with industry trends, technological advancements, and regulatory changes related to solar energy quality standards.

o Always adheres to company procedures and policies.

o Attend and participate in meetings as required.

o Provide support on any special projects as requested.

o Comply with all safety policies, practices, and procedures.

o Other duties as requested.

SCOPE

• Oversees all R&D responsibilities being performed for 10X-Labs

• Oversees, trains, and provides work direction to team

• Provides problem-solving assistance.

• Approves and makes corrections to timecards.

• Assists team members in goal setting and achievement.

• Provides input to Directors and Managers or assists Directors and Managers in providing performance feedback to employees.

• May participate in hiring process.

• Will prepare work schedules.

• Documents, monitors, and controls expenditures in accordance with established budget. May contribute to departmental budget and forecasting process. Approves expenditures in line with signature authorization policy.

REQUIRED QUALIFICATIONS

Education

• Bachelor’s degree in chemistry, Quality Management, Chemical Engineering, or a related field. Master’s degree is desired.

Experience

• Must have at least (5 ) years of experience in a manufacturing setting with powder/liquid raw materials.

KNOWLEDGE, SKILLS, AND CAPABILITIES

• Working Bilingual (Preferably) English/Spanish.

• In-depth knowledge of quality management systems, standards, and methodologies (FDA, NSF, cGMP, ISO 9001, Six Sigma, etc.).

• Strong understanding of supplements, manufacturing processes, and regulatory requirements. Pharmaceutical experience is a plus!

• Must exhibit excellent communication skills.

• Must exhibit excellent leadership skills to include coaching, directing, and supporting direct reports. Must take appropriate disciplinary measures when necessary.

• Must be willing to multi-task and to expect shifting priorities.

• Must have the ability and willingness to delegate tasks to his/her direct reports and follow up for completion.

• Experience in leading quality audits, inspections, and root cause analysis investigations, i.e., FDA, NSF, cGMP, ISO 9001, etc.

• Excellent analytical and critical thinking skills with the ability to implement effective corrective and preventive actions. Understanding of statistical methodologies.

• Demonstrated ability to develop and deliver training programs to enhance quality awareness and skills.

• Initiative-taking mindset with a focus on continuous improvement and driving quality initiatives.

• Relevant certifications such as Certified Quality Manager (CQM) or Safe Quality Food (SQF) are desirable.

• Will need to travel 10% of the time.

WORKING CONDITIONS AND PHYSICAL DEMANDS

• The work environment is that of a fulfillment center or warehouse, specifically one that stores supplement or food products.

• May be required to work weekends, nights, or holidays as a regular part of the job.

• May be designated as a member of the emergency response team. The incumbent is:

o Continuously required to stand.

o Occasionally required to walk or move from place to place.

o Continuously required to utilize hand and finger dexterity.

o Occasionally required to climb, balance, bend, stoop, kneel or crawl.

o Continuously required to use hands and arms in handling, installing, positioning, or moving items.

o Continually required to talk or hear.

o Occasionally required to taste or smell.

o Continuously work near moving mechanical parts.

o Occasionally work around fumes, airborne particles, or chemicals

o While performing the duties of this job, the noise level in the work environment is usually moderate.

• Must

o Occasionally lift and /or move more than 20 pounds.

o Frequently lift and/or move up to 10 pounds.

o Occasionally lift and /or move more than 55 pounds with assistance.

o Specific vision abilities required by this job include close vision; distance vision; color vision; peripheral vision; depth perception and ability to adjust focus.

o Some travel is required.

PERSONAL PROTECTIVE EQUIPMENT

• PPE may be required in certain areas as designated by OSHA.

• Due to safety hazards certain items as defined by OSHA may be prohibited in certain areas.

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The above statements are intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, scope, or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

We are an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law