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 Assurance/Regulatory Affairs (QA/RA)
Associate II in our Louisville, CO location. The QA/RA Associate II position is responsible for all activities associated with Customer Complaints, Investigations, Supplier Qualification and Management, and supporting the Quality Assurance and Regulatory Affairs department as needed.
Activities can include research, interaction with internal Quicksilver Departments, interaction with suppliers, and review of records and documentation. Core Responsibilities include: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Maintain and process all product complaints, including opening and managing investigations pertaining to complaints.
Maintain the Supplier Program. Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
Participate in project teams as assigned. Assist with audits and inspections, including internal, external and FDA inspections. Assist with the CAPA program Assist with kit issuance Perform batch record review Create and revise SOPs as needed. Other QA/RA tasks as required Qualifications: Bachelor's degree in a related field 3-5 years of Regulatory Affairs experience Experience working in a c GMP environment Knowledge of FDA food and dietary supplement product regulations (21 CFR 111, 21 CFR 117, DSHEA) MS Office Suite-intermediate skill level Ideal Candidates have the following traits: Experience with Share Point and Adobe.
c GMP experience in medical, medical device, or dietary supplement industry. Strong interpersonal skills, written, and verbal, proven by effectively presenting information and responding to questions High attention to detail Able to work in a team-oriented environment and follow SOPs and safety protocols Self-starter able to take general direction and work independently and with a team Supports and demonstrates Quicksilver Scientific's core values and behaviors. Quicksilver offers a competitive benefits package including: Employer paid Medical, Dental and Life insurance, including Short-term and Long-term Disability 401(k) with company matching Paid Time Off Paid company holidays Parental Leave Fitness Center membership Generous employee discount program on all QS products Compensation: $ 55,000 to $60,000 per year 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, interactionual orientation, national origin, genetics, disability, age, or veteran status.
This job posting is in compliance with the Colorado " Equal Pay for Equal Work Act. "
