Regulatory Compliance Specialist Position
3 weeks ago
Liquidyne Process Technologies, Inc. is a dynamic and growing company based in Golden, Colorado. We are dedicated to delivering innovative solutions to our clients while fostering a supportive and inclusive workplace.
Job ResponsibilitiesThis Quality Assurance & Quality Control Associate role is responsible for:
- Ensuring Regulatory Compliance: Collaborate with Operations & Engineering on new product requests and ensure regulatory compliance.
- Document Control: Review and approve batch records, logs, and documentation supporting production activities.
- Vendor Management: Develop and maintain quality documentation and oversee the vendor approval process.
- Internal Audits: Conduct internal and external audits for customers, suppliers, and internal processes.
To be successful in this Quality Assurance & Quality Control Associate role, you should have:
- 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.
- 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.
We offer:
- Competitive annual salary: $75,000 - $88,000.
- Health, dental & vision insurance.
- 401(k) plan with company contribution.
- Monthly team lunches & healthy snacks.
- Quarterly team-building events.
- Professional learning opportunities.
- Bi-annual team volunteering and annual holiday parties.
- 10 PTO days & 5 sick days per calendar year.
- 9 paid company holidays.
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