QUALITY ASSURANCE SPECIALIST I

Job Description

This is a local position only. No relocation provided. The QA 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, California Department of Public Health (Food and Drug Branch), ISO/IEC standards and DEA. 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 BRC mission and values.

Responsibilities:

· Sampling and inspection of incoming, in-process and finished products as part of BRC’s manufacturing

· Customer complaints, product investigations, and corrective and prevention action (CAPA)

· Ensure products are being produced in a manner that meets all specifications and brand consistency

· Assist in identifying potential quality risks and working with production and manufacturing personnel to develop improvement opportunities

· The ideal candidate must possess a strong attention to detail and experience working within a highly regulated industry

· Performs finished product sampling and inspection

· Performs line clearances before production grows and or manufacturing runs

· Writes customer complaints and product investigations, helping to assess risk, identify root cause, CAPA plans, and implementing solutions with business partners

· Write QMS documents, including routing and/or approval of change request packages, as requested

· Document control activities

· Keeps up with all quality logs and spreadsheets used for tracking quality systems

· Issues/tracks training when needed

· Inspects packaged orders to ensure correct and accurate content and quantities, as deemed necessary

· Reviews in-process batch documentation to ensure real-time compliance with product specifications, good documentation practices and written policies/procedures

· Reviews in-process batch documentation, logbooks, test results, and good documentation practices contained within the documentation

· Performs reviews and audits as assigned

· Collaborates with operational functions to troubleshoot manufacturing and production defects, CAPA, and customer complaints, if applicable

· Provides advice with process improvements to eliminate errors and reduce risk

· Monitor’s compliance to established Good Manufacturing Practice (GMP) guidance

· Executes action plans for product quarantine, destruction, rework, and withdrawal/recall, if applicable

· Conducts all duties in compliance with safety rules, applicable SOPs, and other applicable guidelines

· Other duties as assigned by the VP of Quality.

Required Experience, Education and Skills:

· Bachelor's degree with 1 year of experience or associate degree with 2-3 years' experience

· Prior quality experience in the highly regulated industries of pharmaceutical, medical device or nutritional supplements is beneficial, but not required

· Highly desirable: FDA GMP experience.

· Prior experience with product sampling, inspection procedures, customer complaints, product investigations, and CAPA

· Ability to follow written procedures and monitor others for adherence to written procedures

· Ability to create or update written procedures with site operations personnel

· Strong written and verbal communication skills

· Detail-oriented

· Utilizes critical thinking to troubleshoot issues, work collaboratively with a team to brainstorm solutions, and implement improvement solutions.

Additional Requirements:

· Must be 21 years of age or older to apply.

· Must comply with all legal and company regulations for working in the industry.

· BRC is an Equal Opportunity Employer, and all applicants will be considered without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

Full-time