Job Title: Quality Assurance Specialist
Department: Informations Technology
Reports To: Compliance Manager
FLSA Status: Exempt
Base Salary: $60,000-80,000
ABOUT OUR COMPANY:
Our philosophy is as simple and clear as our ingredients. If we wouldn’t take it, we won’t make it!
At Physician’s Choice, our mission is to ensure everyone has access to safe, high-quality supplements that actually work. We are positioning ourselves as a leader in the probiotic space by being a probiotic first company, with an emphasis in offering simple, effective broad-spectrum supplements for all.
We have developed strategic partners in the industry that allow us to use superior raw ingredients. We source only from reputable suppliers and manufacture all of our products in the U.S.A.
Logan Chierotti, CEO of Physician's Choice is recognized as a 2020 Titan 100 in Colorado by Titan CEO. Chierotti has turned his supplement company into the fastest growing supplement brand on Amazon. Founded in December of 2017 and since has led the company to $70 million a year and is on pace to hit $100 million in sales. He was able to help disrupt the professional-grade supplement industry and bring quality products to more people at an affordable cost. By focusing on quality products at fair prices, Chierotti’s utilization of the DTC model has made Physician’s Choice an on-going success. Physician’s Choice continues to expand and is being sold online at Walmart.com, Target.com, iHerb, and Groupon. Additionally, we were awarded nationwide distribution into Walmart. Within 17 weeks of launching in Walmart, we are now within the top third of VMS brands within Walmart. This success will allow us to pursue additional retail opportunities with the exceptional A-Player Team Chierotti has built.
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 A-Players that support and live out our core values of Passion, Excellence, and Accountability. 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
Generous self-managed time off program
Work-life balance and a fun environment
Casual dress code
Team building events
Free food & supplements
Professional growth and development within the organization
We are looking for a passionate Quality Assurance Specialist to join our growing compliance team. The Quality Assurance Specialist is 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. The Quality department serves as a key check and balance measure in our operations and requires adherence to and modeling of the highest ethical standards. This role is accountable for knowing and following all company policies and procedures, leads by example, and lives the company mission and values. This is a full-time on-site position.
ESSENTIAL FUNCTIONS: include the following. Other duties may be assigned.
Quality Management System
Update and maintain site master file, facility registrations, training matrix, job descriptions specific to compliance
Document Control & Recordkeeping
Maintain filing system, SOPs + TOCs, approved suppliers, approved products, and QA logs (MRB, deviations, OOS, NCRs, investigations, complaints, change control, testing)
Update all finished product specifications using formulas, labels, and test results COAs
Assist with drafting several quality and regulatory documents including COAs, COCs, formulas, specs, SOPs, logs, and reports
Ensure products are quarantined upon receipt, AQL inspected, retains kept, and samples are sent to approved labs for testing
Maintain files, logs, action items, and next steps for all OOS and NCRs for MRB discussions and formal dispositions of approval, release, or reprocess
Use finished product specifications, product release checklists, and test results to determine whether production lots meet specifications for release
Finished Product Specifications
Assist with drafting each FPS with particular attention to the quality and regulatory sections; review testing methods and labeling and packaging specs
Organize SAQ, GFSI/GMP certification, food defense, food safety, audit reports, test results, and other supplier qualification documents for each supplier
Assist with entering data for supplier scorecard
Labels & Claims Reviews & Substantiation
Perform initial label reviews for compliance with 21 CFR 101 and claims; indicate non-compliant formatting, technical information, or content
Review SFP (supplement facts panel) against technical documentation to ensure accuracy
Streamlines and simplifies existing quality system procedures.
Maintain and update, as required, finished product and packaging specifications to assure product quality.
Review and maintain files of all records pertaining to manufacturing, packaging, testing, incoming shipment inspection, and timely QA release for market distribution.
Establishes guidelines for data collection and reporting procedures.
Conduct periodic reviews of Quality Systems and present them to top management.
Ensure that all procedures and activities performed by suppliers and manufacturers are cGMP (Good Manufacturing Practice) compliant.
Review and facilitate approval of master manufacturing records, planned deviations, change requests, and product releases.
Facilitate manufacturer investigations if a product fails to meet established quality specifications and assure that the root cause of the problem is identified and appropriate corrective actions are implemented to prevent the reoccurrence of the failure.
Provides feedback to managers when non-conformances, omissions and documentation errors are found.
Conduct periodic audits of Material Suppliers, Contract Manufacturers, Contract Distributors and Contract Laboratories.
Conduct internal audits for compliance with 21 CFR Part 111.
Interfaces with employees, customers, or vendors to coordinate and resolve quality-related problems.
Compiles and writes training material and conducts training sessions on quality control procedures.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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.
To perform this job successfully, an individual should have knowledge of Word Processing software; Spreadsheet software; Database software and Project Management systems.
EDUCATION AND/OR EXPERIENCE:
Bachelor's degree (B. A.) from a four-year college or university or 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.
Minimum 3 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
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.
Collaborates - 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.
Customer Focus - Building strong customer relationships and delivering customer centric-solutions.
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. Reasonable accommodations may be made to enable individuals to perform the essential functions.
While performing the duties of this job, the employee is constantly required to sit and use hands to operate the telephone, type, and operate the computer and mouse. Physical effort may include stooping, kneeling, touching, feeling, reaching, standing, walking, pushing, pulling, lifting, fingering, grasping, talking, hearing, and repetitive motions. The employee is frequently required to talk, hear, and bend and twist neck. The employee may occasionally lift and/or move up to 10 pounds and rarely lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and distance vision. Physician’s Choice provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Physician’s Choice complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.