Quality Document Control Specialist

Quality Document Control Specialist

Location: Colorado Springs, CO (On-Site)
Job Type: Full-Time | Hourly (Non-Exempt)

Join a Team That’s Raising the Bar in Nutraceuticals

We are a cutting-edge nutraceutical manufacturer dedicated to creating high-quality, effective, and affordable nutritional products. From custom supplement manufacturing to USDA organic and US Hemp Authority-certified formulations, we take pride in delivering excellence at every step.

Now, we’re looking for a Quality Document Control Specialist to help maintain the accuracy, compliance, and efficiency of our quality processes. If you have a keen eye for detail, a passion for regulatory excellence, and a strong understanding of batch records and quality documentation, this role is for you.

What You’ll DoDocument Control & Compliance

• Organize, track, and maintain quality documentation to ensure accuracy, completeness, and compliance with FDA regulations.
• Review and approve raw ingredient specifications, component specifications, sampling plans, and finished product labels.
• Manage deviations, corrective actions, and quality audits to ensure continuous improvement.
• Keep controlled documents updated, including Standard Operating Procedures (SOPs), protocols, and test records.

Batch Record Management

• Issue, track, and manage batch production records and lot number assignments.
• Ensure accurate logging and timely submission of batch records.
• Investigate and correct any discrepancies in batch records to maintain compliance.

Regulatory Knowledge & Training

• Stay informed on FDA regulations (21 CFR 111, 21 CFR 117), NSF 455-2 standards, and Certified for Sport requirements.
• Train team members on compliance and best practices in quality documentation.

Quality Support

• Assist the Quality Assurance Manager with documentation, audits, and third-party lab management.
• Collect, retain, and organize samples, records, and compliance documents in accordance with regulatory requirements.

What We’re Looking For

• At least 1 years of experience in a cGMP manufacturing environment with quality documentation responsibilities is preferred.
• Strong knowledge of FDA regulations, cGMP, and good documentation practices.
• Experience with Batch Records, including tracking, reviewing, and ensuring accuracy in batch production records.
• Strong mathematical skills, including understanding formulations based on percentages and potencies, proficiency in weighing materials, and ensuring batch records reflect accurate addition, subtraction, and time tracking.
• Exceptional attention to detail and organizational skills.
• Proficiency in Microsoft Office Suite (particularly in Excel).
• Ability to thrive in a fast-paced environment while ensuring strict compliance.

Physical Requirements

• Ability to sit, stand, and walk for prolonged periods.
• Must be able to lift up to 50 pounds as needed.
• Required PPE (facemask, hairnet, gloves, foot covers) while in the manufacturing facility.

Compensation & Benefits

• Pay: $21.63 per hour.
• Benefits: Medical, Dental, Vision, 401(k), PTO, and more.

Equal Opportunity Employer

We are committed to fostering an inclusive and diverse workplace. We do not discriminate based on race, color, religion, gender, sexual orientation, gender identity, national origin, age, marital status, disability, veteran status, or any other legally protected status.

This job posting provides an overview of the role's key responsibilities but does not encompass all duties and expectations.

Job Type: Full-time

Pay: $21.63 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Ability to Commute:

• Colorado Springs, CO 80915 (Required)

Work Location: In person

Salary : $22