Pharma Quality Assurance Specialist I
Job Description
Job DescriptionNO RELOCATION OFFERED and NO SPONSORSHIP FOR THIS POSITION.
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, CDPH (Food and Drug Branch) and ICH standards. 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. This is a full-time on-site position.
The following are an example of essential duties and responsibilities: · Sampling and inspection of incoming, in-process and finished products as part of BRC’s manufacturing. · Deviations/Nonconformances, 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. CORE JOB DUTIES:· Performs finished product sampling and inspection. · Performs line clearances before production grows and or manufacturing runs. · Consults on or identifies deviations 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 (MasterControl)· Keeps up with all quality digital 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 to 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. · Monitor’s compliance to established Good Manufacturing Practice (GMP) guidance. · Executes action plans for product quarantine, destruction, and rework, if applicable. · Conducts all duties in compliance with safety rules, applicable SOPs, and other applicable guidelines. * Other duties as assigned
• 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.