Quality Control Manager - QCM Dietary Supplement Manufacturing

Quality Control Manager - QCM Dietary Supplement Manufacturing Divine Design Manufacturing Richardson, TX Job Details Full-time $70,000 - $80,000 a year 19 hours ago Qualifications Food and beverage product quality management Teamwork Food safety management Operations management Team leadership English Manufacturing facility Supervising experience Math Bachelor's degree Organizational skills FDA regulations Full Job Description Position Summary The QA/QC Manager is a critical leader responsible for overseeing daily quality control operations and safeguarding the integrity of our dietary supplements. This position ensures facility-wide compliance with current Good Manufacturing Practices (cGMP), specifically

FDA 21 CFR

Part 111 and Part 117 regulations. The ideal candidate will act as a regulatory champion, driving continuous improvement, managing quality systems, and supporting the Quality Director and Executive Management in maintaining the highest standards of product safety and efficacy. Core Responsibilities Regulatory Compliance & Auditing  c

GMP Oversight:

Ensure strict adherence to cGMP standards across all manufacturing processes and facility operations. 

Regulatory Expert:

Serve as the facility's Subject Matter Expert (SME) on FDA regulations (21 CFR 111 and 117), interpreting guidelines and implementing compliant processes. 

Audit Leadership:

Act as the primary audit lead for FDA inspections, third-party certification audits, and routine internal management reviews. Quality Operations & Document Control 

Batch Record & Lab Review:

Thoroughly review and approve Master Manufacturing Records (MMRs), Batch Production Records (BPRs), Raw Material Certificates of Analysis (COAs), and QC/Lab Test Reports for raw materials and finished goods. 

Specifications Management:

Review, develop, and approve specifications for both Raw Materials (RM) and Finished Goods (FG). 

Deviation & CAPA Management:

Log, investigate, and address Out of Specification (OOS) results and process deviations. Lead root-cause analysis for manufacturing problems and manage the associated Corrective and Preventive Actions (CAPAs). 

SOP Management:

Review, write, and approve Standard Operating Procedures (SOPs), Work Instructions, and corporate Quality Policies. 

Records Management:

Support, compile, and securely organize all required quality and batch records. Vendor & Materials Management 

Vendor Qualification:

Take full ownership of the Vendor Qualification program, conducting evaluations and reviewing ongoing vendor compliance. 

Materials Oversight:

Lead quality initiatives regarding all raw material and packaging component programs. Leadership & Team Development 

Training Program:

Manage and execute the overall facility cGMP and quality training program for all employees. 

Team Mentorship:

Supervise, train, and assist Quality Associates in performing their daily job functions. 

Executive Support:

Collaborate with the CEO, President, and Executive Management on strategic operational and compliance initiatives as directed.

Organizational Relationships:

Reports to the President/Owner and Quality Director Key Skills & Competencies 

Bilingual:

Fluent in both English and Spanish (highly preferred). 

Communication:

Exceptional written and verbal communication skills for cross- departmental collaboration and regulatory documentation. 

Analytical Thinking:

Advanced problem-solving, logic, and root-cause analysis capabilities. 

Organization:

Superior organizational skills with the ability to manage complex documentation systems and multiple concurrent projects. 

Leadership:

Strong interpersonal leadership skills designed to foster a culture of quality and accountability on the production floor. 

Technology:

Proficiency with modern computer systems, ERPs, and Microsoft Office/quality management software.

Qualifications:

Experience:

5 to 10 years of progressive Quality Assurance/Quality Control experience in the Dietary Supplement, Food, or Pharmaceutical manufacturing industries.

Leadership:

2 to 3 years of direct personnel management or supervisory experience.

Regulatory Knowledge:

In-depth, working knowledge of

FDA 21 CFR

Part 111 (Dietary Supplements) and Part 117 (FSMA/Preventive Controls).

Education:

A bachelor's degree is highly preferred, ideally in a science, chemistry, or biology-based field.

Technical Proficiency:

Strong background in data analysis, statistical methods, and applied mathematics for quality control.

Schedule:

Flexibility to adjust scheduling as needed to support dynamic manufacturing operations. Physical and Mental Demands and Work Environment The physical and mental demands described below are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. 

Physical Demands:

The employee must frequently stand and walk throughout the shift for prolonged periods. The role requires the ability to bend, reach, push, pull, and squat. The employee must safely lift and/or move up to 20 pounds for short distances, occasionally lift up to 50 pounds, and safely maneuver pallet loads using a manual pallet jack. Specific vision abilities required include close, focused vision. 

Mental Demands:

The employee must be able to clearly speak and write in English, interact professionally with internal staff, contractors, and external vendors, and effectively establish priorities while managing multiple high-stakes tasks concurrently. 

Work Environment:

The noise level in the manufacturing and warehouse environment ranges from quiet to moderately noisy. As with all positions at DDM, the employee is strictly responsible for carrying out all duties in a safe, efficient, and responsible manner.

Pay:

$70,000.00 - $80,000.00 per year

Work Location:

In person