Pharma Quality Assurance Specialist I

BIOPHARMACEUTICAL RESEARCH COMPANY; Castroville (CA); In loco; USD 75.000 - 105.000; Tempo pieno

Vantaggi offerti da questo lavoro

401(k)

401(k) matching

Dental insurance

Health insurance

Paid time off

Vision insurance

Descrizione del lavoro

BIOPHARMACEUTICAL RESEARCH COMPANY seeks a QA Specialist to verify our quality program and ensure compliance with FDA, CDPH, and ICH standards. The role is on-site and full-time within a highly regulated manufacturing environment.

The ideal candidate will perform sampling, inspections, deviations investigations, and CAPA planning, while maintaining strict document control and adherence to company policies. Relocation or sponsorship are not offered.

Competenze

• Experience in a highly regulated pharmaceutical manufacturing environment.
• Strong attention to detail and accuracy.
• Knowledge of GMP guidelines and FDA/CDPH/ICH standards.

Mansioni

• Verify quality programs and ensure compliance with government regulations.
• Perform sampling and inspection of incoming, in-process and finished products.
• Review batch documentation and quality systems records for accuracy and compliance.
• Develop and implement CAPA plans in collaboration with production.
• Maintain documentation controls and write QMS documents when needed.
• Support training and assist with product quarantine, destruction, or rework as required.

Conoscenze

Attention to detail

Regulatory compliance

Quality assurance

Strumenti

MasterControl

Descrizione del lavoro

Benefits

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

NO 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.

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.