Direct message the job poster from Physician's Choice®
Liz Hyman
Chief People Officer at Physician’s Choice
We are looking for a passionate Quality Systems Specialistto join our growing team on our mission of becoming the #1 Probiotic Supplement Company in the US. This person will be responsible for verifying the Company’s quality program by using established quality policies to measure, monitor, and ensure compliance with government regulations as they relate to dietary supplements. This role is accountable for knowing and following all company policies and procedures, leading by example, and living the company mission and values. This is a full-time on-site/hybrid position that reports to the Director of Quality.
The ideal candidate has knowledge of FDA regulations and guidelines, an understanding of good documentation practices and document/records controls and experience working in a Quality role in support of cGMP manufacturing or similarly regulated environments.
What You’ll Do:
● Quality Management System Support
○ Maintain site master file, facility registrations, training matrix, and job descriptions specific to compliance.
○ Coordinate with the team to administer routine traceability and mock recall exercises with co-manufacturers and 3rd party logistics to confirm regulatory compliance.
○ Develop, implement, and manage Policies, Procedures, and Work Instructions to ensure compliance with 21 CFR part 111 and 101 requirements.
○ Perform internal audits to confirm compliance with 21 CFR Part 111 and 101.
○ Provide feedback to managers when non-conformances, omissions, and documentation errors are found.
○ Conduct periodic reviews of Quality Systems and present them to top management.
○ Compile and write training material and conduct training sessions on quality control procedures.
● Vendor Compliance
○ Maintain up to date supplier compliance documentation confirming compliance with FDA Current Good Manufacturing Practices (cGMP), 3rd party certification, and internal quality management systems to qualify new and existing suppliers.
○ Co-own Supplier Non-Conformance Reporting procedure if a product fails to meet established quality specifications or requirements to determine the root cause of the problem.
○ Development and analytics of Supplier Non-Conformance Reports including the development and implementation of Corrective and Preventive Actions.
○ Participate in Material Review Board meetings to provide dispositions for the release or rework of out-of-specification finished goods.
● Customer Support
○ Voice of the Customer- Coordinate with Customer Service to define and incorporate customer requirements into specifications and business processes.
○ Coordinate with Supply Chain and Inventory to ensure 3PL deliveries of product to fulfillment centers meet requirements.
○ Coordinate internally to drive customer complaint reduction initiatives and identify and implement corrective and preventive actions.
● New Product Development
○ Support Product Development, Brand, Creative, and Marketing to drive adherence to the New Product Development process.
○ Coordinate with Quality team to develop new product specifications, Bill of Materials (BOM), master manufacturing records, and COA templates.
● Back up and support Quality Specialist and Director of Quality, as needed.
Requirements:
EDUCATION AND/OR EXPERIENCE:
Bachelor's degree (B. A.) or Associate's degree (A. A.) from a four-year college or university in a related field required.
Minimum 2 years of experience working within Quality in support of cGMP manufacturing or similarly regulated environment.
Working knowledge of FDA regulations and guidelines, including 21 CFR part 101, 111, and 117.
Understanding of Good Documentation Practices and Document/Records Controls.
Relevant certifications such as PCQI, HACCP, or Quality Auditor preferred.
QUALIFICATIONS:
Ability to read, analyze, and interpret common scientific and technical documents.
Ability to perform root cause analysis and implement appropriate CAPAs.
Ability to understand and calculate basic formula inputs for comparison against label claims and technical documents.
Knowledge of Word Processing software; Spreadsheet software; Database software, and Project Management systems.
CORE COMPETENCIES:
Action Oriented – Taking on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm.
Resourcefulness – Securing and deploying resources effectively and efficiently.
Collaborative - Building partnerships and working collaboratively with others to meet shared objectives
Self-Development - Actively seeking new ways to grow and be challenged using both formal and informal development channels.
Situational Adaptability – Adapting approach and demeanor in real time to match the shifting demands of different situations.
Decision Quality – Making good and timely decisions that keep the organization moving forward.
Optimizes Work Processes – Knowing the most effective and efficient processes to get things done, with a focus on continuous improvement.
Our founder, Logan Chierotti, almost lost his hearing as a teenager. When modern medicine couldn't help, natural supplements restored his hearing. This life-changing moment inspired Logan to establish Physician's Choice in 2017. After 5 years of extraordinary sales growth, Physicians Choice is on pace to do over $150MM in sales and is the # 1 probiotic brand on Amazon, with Brick and Mortar distribution in Walmart, Target, CVS, SAMs Club and over 70,000 retail touch points.
Our mission is to empower every body to make confident wellness choices, guided by physician expertise and validated by real results. We do this by collaborating with leading physicians to develop straightforward, accessible probiotic supplements that deliver on promises. Join our passionate team and be part of a company making a real difference in people's lives.
WHAT'S IN IT FOR YOU:
Our commitment to quality and transparency applies not only to our products but to our people. We are focused on creating a fun, exciting, collaborative space that’s centered around health and well-being. We continue to grow Physician's Choice with Team Players that support and live out our core values of Passion, Curiosity, Proactiveness, Resourcefulness, and Getting Sh@# Done. We empower everyone on our team to take control of their careers and balance their work and life in a modern, fast-paced environment.
We offer an exceptional compensation package which includes:
Day one health benefits with multiple options to best fit your healthcare needs
401k match up to 4%
Paid maternity and parental leave
$150/quarter wellness benefit
$75/month cell phone reimbursement
$100/month in free company product
Free lunch twice a week in our Wheat Ridge Office
Free office snacks
Seniority level
Associate
Employment type
Full-time
Job function
Quality Assurance
Industries
Wellness and Fitness Services
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