Associate, Quality Systems

3 months ago

Chatsworth, United States Vytalogy Wellness, LLC Full time

Overview:

Title: Quality Systems Associate

Location: Chatsworth, CA

Company Summary:

Vytalogy is a modern wellness company, - we bring a vibrant energy to life. Headquartered in Sherman Oaks, CA, Vytalogy markets products across multiple channels and categories in vitamins, minerals, and supplements (VMS). Our incredible brands, Natrol and Jarrow Formulas, are recognized and trusted as industry leaders for over 85 years. We bring together exceptional talent and harness diverse backgrounds and perspectives to make life more vibrant for everyone, every day.

Position Summary:

The QS Associate will supervise the activities with development, application, training, and maintenance of quality standards for industrial processes at Vytalogy Wellness. The QS Supervisor will also be assisting with ensuring that all products meet the established quality standard according to The Code of Federal regulations Title 21- Food and Drugs. This position supervises the Quality System Training, Material Reviews and Disposition (MRD/MRB) and assists Consumer Affairs with investigating and approving Consumer Complaints.

This position provides support to the QA/QC, R&D, Production/Procurement departments, and Technical Support/Consumer Affairs group.

Responsibilities:

Your primary activities will include but are not limited to:

  1. Facilitates the change control process across Vytalogy sites.
  2. Coordinates with the Consumer Affairs team on Non-serious Adverse Events and follows up on the non-SAERs forwarded by Consumer Affairs to QS.
  3. Facilitates all the complaints process including complaint investigations, the supplier quality program as well as the Material Review Board process.
  4. Logging, routing, follow-up, implementation, and closure of all change controls.
  5. Assist with the CM incoming quality inspections review and final lot release.
  6. Ensures the reviews and coordination of vendor raw material CofAs, product specifications, SDS, and other product-related information from vendors, as instructed by supervisor/manager.
  7. Assist with the Document Controls DCR/SOPs/Training Documentation.
  8. Assist with Deviations/ CAPA and non-conformance tracking and follow-ups.
  9. Assist with the creation finished products, bulk products and raw material specifications sheets in accordance with The Code of Federal regulations Title 21- Food and Drugs 111.70
  10. Assists the department with any tasks related to cGMP implementation and maintenance.
  11. Coordinates with the Consumer Affairs on the investigation of on-serious Adverse Event Reports, and other customer complaints.
  12. Create and revise SOPs, approve Material Reviews and change control, and assist with any necessary training and implementation of Quality procedures.
  13. Performs any other related duties as may be required by the Supervisor.


Qualifications:

Youll need the following (minimum qualifications):

  • 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 with disabilities to perform the essential functions.
  • While performing this job, the employee must occasionally alternate between sitting and standing positions. The employee frequently is required to reach with hands and arms, use hands and fingers to handle controls, computer and mouse; talk and hear. The employee is occasionally required to walk, stand, stoop, and lift as required to file documents or store materials throughout the workday.
  • Specific vision abilities required by this job include close vision and the ability to adjust focus. Proper lifting techniques required. May include lifting to 50 pounds for files, computer printouts on occasion.
  • BA/BS in Chemistry or related discipline with 1 year experience in a QA/QC environment; or, 2-4 years experience in a QA/QC environment.
  • Knowledge/ Experience in cGMP and other pertinent regulations

cGMP and regulatory knowledge of relevant FDA and global stability guidelines.

  • Excellent analytical and problem-solving skills and written and verbal communication.
  • Experience with regulatory inspections would be advantageous.
  • Ability to work in a fast-paced environment and to value the importance of teamwork

A reasonable estimate of the current base hourly/salary range for this position is $22.00 to $24.39. Actual compensation offered may vary depending on skill level, experience, and/or education. [Vytalogy Wellness LLC offers a competitive total rewards package, which includes medical, dental, and vision insurance, 401K with company matching contributions, paid sick days, vacation, and holidays, paid parental leave, short-term and long-term disability coverage, life insurance, and wellness programs.]

Vytalogy Wellness, LLC is an Equal Opportunity Employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law.

Vytalogy Wellness, LLC collects personal information of job applicants in connection with our recruitment and hiring activities. For more information, including the categories of personal information we may collect, the purposes for which we collect such personal information and the rights you can exercise over our use of your personal information, see our Notice of Collection for California Employees, Job Applicants and Contractors

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