Quality Assurance Specialist

2 weeks ago

Ontario, California, United States Everest Formulations Full time
Everest Formulations is a turnkey dietary supplement manufacturing company.

The Quality Assurance Specialist supports activities required for the Quality Management Systems and reports on its performance against set metrics and standards.

This individual will work with managers and staff throughout the organization to ensure that the Quality Management Systems are functioning properly.


Essential Job Duties

  • Essential job functions and duties include, but are not limited to, the following:_
  • Support and ensure compliance with organic certified standards including maintaining organic workbooks to certify suppliers are updated as needed. Participate and support certified organic audits.
  • Create and review cGMPrelated SOPs and forms to ensure adequate execution by personnel and compliance with related cGMP regulations.
  • Review and oversee company documents including but not limited to quality batch records, change control forms, control of nonconformance documents, and training materials.
  • Maintain, investigate, and document Customer Complaints. Track and trend data for reporting.
  • Escalate noncompliance to Quality Supervisor/ Manager and follow up on timely corrective actions.
  • Implement effective change control program including training on proper documentation and approvals.
  • Conduct mock recalls annually. Document any findings and corrections.
  • Maintain, investigate CAPA including performing effectiveness checks.
  • Maintain HACCP program including creation of flow charts, hazard analysis and food safety plan.
  • Assist/conduct internal and external inspections, thirdparty audits, and customer onsite audits.
  • Determine opportunities for improvement of company document control system.
  • Review and approval of Master Batch Records, Master Packaging Records, formulas, and specifications.
  • Review documents for Supplier Qualification process including maintaining Approved Supplier List.
  • Perform regular employee Compliance training (GMP).
  • Interact with other departments to provide QA and food safetyrelated information to be compliant with FDA, cGMP and customers quality and compliance requirements.
  • Understand approved regulatory policies and standard operating procedures including the regulations under 21 CFR Part 111, and 21 CFR Part 11
  • Responsible for creating and maintaining reports including but not limited to quality data trending on QMS.

Qualifications

  • 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, skills, education and/or abilities required for the job.
Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential job functions:
_

Job Knowledge, Skills & Abilities:

  • Develop standard operation procedures, prepare audit tracking system, audit communications, staff training, audit responses, reporting, and compliance with audit deadlines.
  • Strong knowledge of production methods/systems, continuous improvement processes, problem analysis and resolution.
  • Manage deviation control process.
  • Train and support QA team on quality procedures, protocols, and documentation.
  • Coordinate investigation of quality issues with customers and suppliers.
  • Thorough knowledge of methodologies of quality assurance and standards.
  • Excellent numerical skills and understanding of data analysis/statistical methods.
  • Excellent verbal and written communication skills. (Bilingual English /Spanish a plus)
  • Outstanding planning and organizing skills as they relate to quality processes.
  • Strong knowledge of continuous improvement processes, problem analysis and resolution.

Selection Guidelines

  • The appropriate knowledge, skills and abilities required for this position are achievable through the following combination of education, work experience and training:_
  • Bachelor's degree in relevant a field (e.g., Biology, Chemistry, Engineering, or related discipline).
-
Minimum of 3-4 years of experience, working within a regulated environment in the Nutraceutical/Pharma industry. Knowledge of 21 CFR Part 11 regulations a plus.

  • Proficient with Microsoft Excel, Word, Outlook, and Google Docs.

Physical Demands & Work Conditions

  • The essential functions of this job require the employee to perform the following physical activities during the course of work:_
  • Required to stand, walk, and sit for extended periods of time during course of work shift.
  • Required to regularly stoop, bend, kneel, lift, and reach, in the performance of this role.
  • Required the use of hands, speech and hearing, and use of feet to operate machinery/equipment; Agility to operate and frequently be exposed to moving mechanical parts.
  • Lifting requirements: 2535 lbs.; and the ability to move/push up to 25 lbs.
  • The noise level in this work environment may be moderate to high.
  • Occasionally exposed to high, precarious places,

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