Quality Associate II

Mile High Labs (“MHL”) is an exciting company with incredible potential that powers the world’s novel consumer packaged goods. Our quality commitment is a promise we keep throughout our entire process—from the farm to the lab, to the customer. Our portfolio of hemp-based cannabinoid ingredients is trusted by leading global brands, in creating a generation of innovative consumer products. The company's adherence to the strictest manufacturing certifications and commitment to self-regulation has earned the trust of brands around the world. For more information, visit milehighlabs.com.

Embrace this chance to grow with us, where your passion for wellness and the environment drives a career that's as impactful as it is inspiring.

Position Title: Quality Associate II

The Quality Associate II will assist the Manager, QA with all QA systems, i.e., finished product release, quality inspections, manufacturing process controls, training, investigations, etc. The position will provide quality oversight of internal operations in support of best practices.

Compensation and Benefits: Salary Range $65,000-$75,000. Comprehensive Benefits Package, Medical, Dental, Vision, FSA Benefits, 401K and Paid Time Off (PTO) * A great team environment * Entrepreneurial environment * Diverse and inclusive workplace where we all learn from each other * Ongoing training, development, and support for a career in the CBD/Cannabinoid industry.

Essential Responsibilities & Duties: 

• Maintain product quality by establishing and enforcing quality standards.
• Perform all work under ISO 9001, 21 CFR 111/117, Colorado state regulations, safety policies, and other applicable regulations or standards.
• Execute daily quality inspections, sampling and dispositioning of incoming materials, in-process materials, labeling, final ingredient, and finished good reviews.
• Provide quality oversight of internal operations and contract manufacturers.
• Produce work using good manufacturing practices and good documentation practices across the organization to ensure compliance.
• Draft, review, and approve all procedures and controlled documents relating to good manufacturing practices.
• Generate, review, and approve material and product specifications.
• Develop and maintain document control activities including, filing, scanning, and archiving electronic and hard copy controlled documents in an organized manner.
• Provide analysis to mitigate hazards, support process validations, and produce protocols/reports.
• Conduct and support hazard analysis and failure modes and effects analysis.
• Conduct or assist, review and approve investigations, incident reports, risk assessments, change controls, complaints and implementation of Corrective Action and Preventive Actions.
  
• Support, review, and approve process validations and equipment qualifications as needed.
• Support and execute bulk hold studies to include generating protocols/reports, sampling, and inspecting
• Support stability program, including coordinating third-party laboratories, protocols, data interpretation, and reports.
• Conduct external/internal audits and support compliance/customer audits.
  
• Coordinate sample management; routing, shipping, and sample submission through third-party portals. 
• Review and approve executed production batch records and associated forms, logs, and records.
• Manage 3rd party laboratory sample submission, results, data entry and communication to the broader team.
  
• Manage raw material sample testing and communicate with 3rd party labs regarding expected turn-around-times.
  
• Communicate with 3rd party labs regarding new testing capabilities or needs as they arise.
• Work with quality management to resolve 3rd party laboratory OOS to ensure correct testing protocols, methods and results
• Manage sample retain program
• Collect, organize and manage the storage and disposal of retain samples for each lot of manufactured ingredients.
  
• Must follow hazardous waste procedures when selecting, marking, labeling, inspecting, moving, or otherwise handling hazardous waste containers, or reading and applying federal and or/state hazardous waste regulations or record keeping requirements.
  
• All other tasks as assigned.

Qualifications/Educational/Skills and Experience Requirements:

•  Bachelor’s degree in biology, chemistry, or related field is required.

• Minimum of 3-years GMP manufacturing experience with quality oversight is preferred.

• Experience with electronic QMS is preferred.

• Laboratory data interpretation experience.

• Working knowledge of MS Office (Word, Teams, Outlook) and basic Excel knowledge.

•  Intermediate communication (written and verbal) skills to deliver more complex information effectively.

• Intermediate problem-solving skills to be able to manage complex tasks and work through a solution with little guidance and direction.

• Basic troubleshooting skills to work through problems and identify potential solutions.

• Ability to interpret regulations and standards as applicable to MHL products cosmetics/dietary supplements/hemp derived cannabinoids and markets US/international.

Equal Opportunity
MHL is committed to equal employment opportunity and to compliance with federal anti-discrimination laws. We also comply with Colorado law, which prohibits discrimination and harassment against any employees or applicants for employment based on disability, race (including hair texture, hair type or protective hairstyles commonly or historically associated with race (e.g., braids, locs, twists, tight coils or curls, cornrows, bantu knots, afros and headwraps)), color, creed, sex (including pregnancy), religion, age (over 40), national origin, sexual orientation, gender identity, gender expression, marital status, ancestry, state National Guard status, civil air patrol status, and lawful activities during nonworking hours. The Agency also does not discriminate against qualified applicants because they did not apply through a private employment agency. MHL generally does not discriminate against employees or applicants for employment solely because they are married to a co-worker. However, exceptions exist where, for example, one employee exercises supervisory authority over, audits, or has access to the Agency’s confidential information about the other. MHL will not tolerate discrimination or harassment based upon these characteristics or any other characteristic protected by applicable federal, state, or local law.