Quality Assurance and Quality Control Associate

We are a dynamic, growing company in beautiful Golden, Colorado, seeking a talented Quality Assurance & Quality Control Associate to ensure excellence in product quality and compliance.

What You’ll Do

As a QA/QC Associate, you’ll play a critical role in upholding Liquidyne’s commitment to quality. Your key responsibilities will include:

• Documentation & Inspection:

• Review and approve batch records, logs, and documentation supporting production activities.

• Conduct quality control checks on products, labels, and packaging to meet internal standards.

• Prepare and finalize Certificates of Conformity (CoC) for sterile single-use products, including gamma irradiation documentation.

• Regulatory & Compliance Support:

• Collaborate with Operations & Engineering on new product requests and ensure regulatory compliance.

• Create, review, and approve changes to processes and documents, guiding teams on regulatory requirements.

• Provide guidance on cGMP principles and applicable FDA (21 CFR 820) and ISO 13485 regulations.

• Audits & Investigations:

• Support internal and external audits for customers, suppliers, and internal processes.

• Lead root cause investigations and corrective action plans for identified quality issues.

• Documentation & Vendor Management:

• Develop and maintain quality documentation, such as validation protocols, site master plans, and procedures.

• Oversee the vendor approval process, ensuring supplier compliance with quality standards.

• Customer Interaction:

• Respond to customer requests, including surveys and evidence of quality systems, and support onboarding activities.

What We’re Looking For

We’re searching for a detail-oriented, collaborative professional who brings:

• Education & Experience:

• Bachelor’s degree in a science-related field (e.g., biology, chemistry).

• 3-5 years of quality assurance experience, including 1-2 years in regulatory roles within cGMP manufacturing environments.

• Skills & Expertise:

• Experience with audits (internal or external), cleanroom environments, and sterile/single-use assemblies.

• Familiarity with sterilization validation (ISO 11137), environmental monitoring, and ISO 9001/13485 standards.

• Strong problem-solving skills for root cause analysis and quality improvement.

• Excellent attention to detail, confidentiality, and professionalism in client and team interactions.

What We Offer

At Liquidyne, we believe in investing in our team. We offer:

• Compensation: $75K–$88K annually

• Benefits:

• Health, Dental & Vision Insurance

• 401(k) Plan with company contribution

• Perks:

• Monthly team lunches & healthy snacks

• Quarterly team-building events

• Professional learning opportunities

• Bi-annual team volunteering and annual holiday parties

• Time Off:

• 10 PTO days & 5 sick days per calendar year

• 9 paid company holidays

Why Join Liquidyne?

We’re a collaborative team passionate about delivering innovative solutions to our clients while fostering a supportive and inclusive workplace. Located in the vibrant Golden area, our office offers a fantastic environment for personal and professional growth.

Apply Today!

Be part of a company that values innovation, quality, and team success. Submit your resume and let’s make a difference together!