Quality Specialist - Remote

We are looking for a positive, driven, and detail-oriented Quality Specialist to join our growing team on our mission of staying 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 such as FDA. This individual will work closely with Physician’s Choice internal and external stakeholders (including but not limited to marketing, quality, 3rd Party Suppliers, raw material suppliers, regulatory agencies, trade associations, etc.) to support new product development, supply chain, and sales in commercializing new products that are safe, efficacious, high quality and compliant with all applicable regulations.

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:

• Perform comprehensive reviews of Batch Records and Certificates of Analysis (COAs) to ensure compliance and completeness.
• Manage the Retain Sample Review process and oversee Product Release in accordance with internal quality standards.
• Conduct MMR (Master Manufacturing Record) and PMR (Product Manufacturing Record) reviews during pre-production phases.
• Manage and submit formal Change Requests and follow through on implementation and documentation.
• Review, investigate, and track resolutions for Customer Escalations and Adverse Events.
• Submit Serious Adverse Events (SAEs) to the Safety Reporting Portal in a timely and compliant manner.
• Perform Finished Product specification sheet updates. 
• Coordinate with Contract Manufacturers to investigate and resolve finished product issues related to batch documentation and retain samples. Sample testing coordination. 

Requirements: 

EDUCATION AND/OR EXPERIENCE:

•  Bachelor of Science Degree in related field (ex. Biology, Chemistry, Food Science, Nutrition etc) an equivalent combination of four to six years related experience and/or training; or equivalent combination of education and experience sufficient to successfully perform the key accountabilities of the job.

Years of experience:

• Minimum 1-3 years of experience working within Quality in support of cGMP manufacturing or similarly regulated environment.
• Experience in dietary supplements is a plus

Type of Experience:

• Working within Quality in support of cGMP manufacturing or similarly regulated environments.
• 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.

Technical Skills:

• Ability to read, analyze, and interpret common scientific and technical documents.
• Ability to perform investigations related to Quality complaints, Adverse events. 
• Ability to understand and calculate basic formula inputs for comparison against label claims and technical documents.
• To perform this job successfully, an individual should have knowledge of Word Processing software; Spreadsheet software; Database software and Project Management system

Soft Skills:

• Strong communication skills, problem solving skills, attention to detail

QUALIFICATIONS:

• Ability to read, analyze, and interpret common scientific and technical documents.
• Ability to review technical documentation for accuracy and identify errors.
• Ability to understand and calculate basic formula inputs for comparison against label claims and technical documents (COAs, Finished Product Specifications, Batch records).
•  Knowledge of Word Processing software; Spreadsheet software; Database software, and Project Management systems.

ABOUT OUR COMPANY:

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 7 years of extraordinary sales growth, Physicians Choice is on pace to do over $200MM 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 everybody 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
• Paid Holidays
• Generous self-managed paid time off program
• Work-life balance and a fun environment
• Casual dress code
• Mentorship Program
• Professional growth and development within the organization
• Company Annual Bonus, 6-24% bonus targeted dependent on hitting annual goals
• Stock Appreciation Rights Bonus Program