Location: Louisville, CO
Company: Quicksilver Scientific
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. "
Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.
Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.
Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.
with the implementation and maintenance of the Branch Quality Management system including; QC Plan, laboratory accreditation, QC/QA project management and supporting technical staff. This position requires an advanced course of study and the consistent exercise of discretion and judgment in analyzing and interpreting information before making reasoned recommendations.
Project locations vary across the United States. Must be willing to travel. Project Mobility pay is offered by GSA rates. Essential Job Accountabilities Implement Quality Management System and policy to ensure materials meet quality standards by analyzing and interpreting testing results. Analyze customer and project requirements
and internal cost structure to develop project budgets. Further management support includes overseeing the billing and work order process to ensure project profitability is achieved.
Evaluate laboratory programs and testing protocols and make recommendations in order to facilitate state and national lab accreditation programs. Review and analyze Technician certification requirements and evaluate Technician compliance. Support projects by analyzing project data and communicating recommended courses of action, including the propriety of obtaining third-party verification of testing results. Further support projects by interpreting Granite internal and owner/agency requirements and preparing
quality control plans. Evaluate project requirements and use quality control software to prepare tracking databases designed to ensure satisfactory project completion.
Supervise technical staff to ensure compliance with quality programs. Evaluate Technician performance and assist management with job performance coaching. Evaluate vendor performance including services provided by third-party engineering firms. Apply substantive expertise during pre-bid, construction, and post construction phases of a project by working with plants/materials, construction, sales and estimating teams to ensure quality standards and project profitability are achieved.
Evaluate proposed courses of action for safety, contract compliance, and profitability and propose alternative courses of action where appropriate. Provide training for QC Engineer Level I and to other technical Quality Management staff. Assist with customer service issues to ensure customer satisfaction levels are maintained Participate in and promote Granite's safety procedures to promote a safe working environment including assistance with safety meeting and inspections. Comply with OSHA and MSHA rules and regulations in order to perform duties in a safe manner. Education/Certification BS in Engineering or related field required Registered Professional Engineer required Work Experience 4 years required Knowledge, skills, and abilities Strong organizational skills Good oral and written communication skills Advanced Microsoft Suite and database operations skills required Self-motivated Training Skills Good understanding of laboratory and field testing procedures and equipment Physical Demand The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to talk and hear.
The employee frequently is required to stand, walk, sit and use hands to operate a computer keyboard. The employee is occasionally required to reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Additional requirement Valid driver's license and ability to drive Our Benefits at a Glance: Building tomorrow starts with you, and Granite knows that you can excel only if we support you in and out of the workplace.
That is why we offer a broad benefits package that includes paid holidays, sick leave, medical, dental, vision, life insurance, disability insurance, flexible spending plans, as well as special programs for musculoskeletal health, mental wellness, and more. Salaried employees may choose from two PPO medical plans through Anthem Blue Cross, including our most popular plan, for which 100% of the premium is paid by Granite for eligible employees and dependents.
Employees can also opt into a Health Savings Account (HSA) or a Flexible Spending Account (FSA). As part of our investment in your future outside of the workplace, Granite provides a 100% match on the first 6% of eligible compensation that salaried employees defer into their 401(k) plans, which vests immediately. Benefits may vary for positions located outside of the continental United States. Base Salary Range: $73,186.00 - $109,779.00Pay may vary based upon relevant experience, skills, location, and education among other factors. About Granite Construction Incorporated Granite Construction Incorporated is a member of the S&P 400 Index and is the parent company of Granite Construction Company, one of the nation's largest heavy civil contractors and construction materials producers.
Granite Construction is an Affirmative Action/Equal Opportunity Employer of Minorities, Females, Protected Veterans, Individuals with Disabilities and a Drug-Free Workplace. For additional information on applicant/employee rights please clickhere. Notice to Staffing Agencies Granite Construction, Inc. and its subsidiaries (" Granite" ) will not accept unsolicited resumes from any source other than directly from a candidate.
Any unsolicited resumes sent to Granite, including unsolicited resumes sent to a Granite mailing address, fax machine or email address, directly to Granite employees, or to Granite's resume database will be considered Granite property. Granite will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Granite will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. Agencies must obtain advance written approval from Granite's recruiting function to submit resumes, and then only in conjunction with a valid fully-executed contract for service and in response to a specific job opening.
Granite will not pay a fee to any Agency that does not have such agreement in place. Agency agreements will only be valid if in writing and signed by Granite's Human Resources Representative or his/ her designee. No other Granite employee is authorized to bind Granite to any agreement regarding the placement of candidates by Agencies.
