Demo

Quality Control Associate I

Quicksilver Scientific, Inc
Louisville, CO Full Time
POSTED ON 1/17/2025
AVAILABLE BEFORE 4/11/2025

Job Description

Job Description

Quicksilver is a pioneer in the natural health industry. Our mission is to deliver on the promise of natural medicine to optimize quality of life.

We envision a company with an environment of collaboration & ideation that leads to innovations that break barriers in the quest for healthier lives.

We value :

  • Craftmanship & Integrity our products are crafted with premium ingredients and backed by science
  • Agility, Audacity & Innovation we pivot and adapt in order to take chances and lead the way in natural health
  • Continuous Improvement & Learning constant iteration and improvement is our hallmark
  • Self-Awareness we strive for self-reflection and authenticity
  • Mutual Respect, Openness & Exchange our teams work across functions with collaboration and reciprocity key to success

Our growth is fueled by individuals who share our passion. Currently, we have an opening for a Quality Control Associate I in our Louisville, CO location.

The Quality Control Associate I is responsible for activities involving quality assurance and compliance with applicable FDA cGMP requirements. This person provides oversight of Production QC operations with hands-on participation as needed, as well as management of various Quality Systems.

Core Responsibilities include :

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Production QC :

Responsible for overseeing Production Line clearance and providing backup when needed

Provide oversight of on-time Batch Release and backup support as required

Review and approval of Document Change Requests as needed

Conduct finished product label inspection and release

Support for resolution of complex Deviation and Nonconformance Reports

System design, support, and organization of retention sample program, oversight of on-time Finished Product testing with backup support as required

Environmental Monitoring Plan :

Oversee data collection (swabbing) protocols

Evaluate the frequency of monitoring, train personnel who support monitoring, and collaborate with production personnel to create training and / or monitoring plans

Review and approve environmental temperature monitoring on-site and pest control (ECOLAB)

Instrument Calibration :

Oversee all in-use calibrated equipment in production

Schedule calibration and assess the frequency of maintenance

Maintain documentation and certificates of calibrated equipment

Provide subject matter expert guidance on the calibration program for all internal and external audits as needed

Internal Audits :

Provide support in the production areas / topics that require audit.

Material Review Board (MRB) :

Gain expertise in the theory and approach, work toward full participation and associated Investigation management and resolution including CAPAs as appropriate

Training :

Provide support to coaching and training of other cGMP employees as needed.

Other QA / QC tasks as required

Qualifications :

Applied Science or associate degree in a comparable field

1-2 years of experience in a comparable field

1-2 years of cGMP experience

MS Office Suite-intermediate skill level

Must be able to walk, bend, stoop, and operate instrumentation requiring hand dexterity.

Ideal Candidates have the following traits :

2 years of cGMP experience

Applied Science or associate degree in a comparable field

Data entry proficiency such as would be acquired in 1 year of experience with an ERP or other complex software

Knowledge of measurement instrumentation

Experience with finished product testing and sampling

Experience with 21 CFR Part 111 Dietary Supplements

Technical writing experience (SOP, Regulatory submissions, technical reports)

High attention to detail

Ability to work in a team-oriented environment and follow Standard Operating Procedures and safety protocols

Ability to train and coach new and / or junior QC staff and other cGMP employees as assigned

Self-starter with the ability to take direction and work independently

Must be able to read and write English

Good organizational skills and detail-oriented.

Quicksilver offers a competitive benefits package including :

Employer paid Medical plan with additional employee-paid offering

Employer paid Life insurance, Accidental Death & Dismemberment, Short-term & Long-term Disability

Dental Insurance

Pet insurance discounts

Legal Insurance

HSA with company matching

FSA options including dependent care FSA

401(k) with company matching

Paid Time Off

Paid company holidays

Fitness Center membership

Generous employee discount program on all QS products

Compensation :

23.00 to $26.00 per hour

Posting Closing Date : 01 / 30 / 2025

Quicksilver Scientific is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

This job posting is in compliance with the Colorado "Equal Pay for Equal Work Act."

Salary : $23 - $26

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