GMP Compliance Coordinator

Our purpose is to bring hope to life by enabling lifechanging therapies for patients around the globe creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients lives by bringing new biopharmaceuticals to market.

JOB SUMMARY

The GMP Compliance Coordinator is responsible for ensuring adherence to Good Manufacturing Practices (GMP) regulations across all areas of our supply chain operations. The GMP Compliance Coordinator plays a key role in maintaining product quality compliance with regulatory standards and continuous improvement initiatives within the organization.

ESSENTIAL JOB DUTIES/RESPONSIBILITIES

• Monitor Raw Material procurement storage handling and distribution comply with applicable GMP standards and regulations.

• Monitor and evaluate GMP compliance throughout the supply chain and identify potential areas of improvement.

• Maintain up to date GMP compliance documentation including SOPs work instructions and compliance reports.

• Prepare and review internal and external audit reports ensuring compliance with regulatory requirements.

• Coordinate with internal teams and suppliers to resolve compliancerelated issues and implement corrective actions.

• Develop and deliver GMP training programs for supply chain staff ensuring they are wellversed in GMP standards and practices.

• Provide ongoing support and guidance on GMPrelated topics to teams within the organization.

• Assist with preparation for GMP audits by regulatory bodies clients and thirdparty certifiers.

• Support internal and external audit activities ensuring that all noncompliance findings are addressed promptly.

• Work closely with the Quality Assurance team to ensure alignment with product quality standards.

• Investigate and report any deviations from GMP procedures ensuring appropriate corrective actions are implemented.

• Actively participate in continuous improvement initiatives to enhance GMP processes across the supply chain.

• Recommend and implement strategies to improve efficiency and effectiveness while maintaining compliance.

SKILLS

• Experience with documentation and report writing including audit preparation.

• Exceptional attention to detail and organizational skills.

• Excellent communication and interpersonal skills with the ability to work crossfunctionally.

QUALIFICATIONS

Required:

• Bachelors degree in supply chain management Industrial Engineering Life Sciences or a related field or equivalent education and experience may substitute for stated requirements.

• Minimum of 35 years of experience in supply chain management GMP compliance or quality assurance within a regulated environment.

• Indepth knowledge of GMP regulations (FDA EMA etc.) and industry standards.

• Strong understanding of supply chain operations and regulatory requirements.

• Proven ability to identify and resolve compliance issues and implement corrective actions.

Preferred:

• Certification in Quality Management or GMP compliance (e.g. ASQ Certified Quality Auditor Certified GMP Professional).

• Experience in the pharmaceutical biotechnology or food industries.

• Knowledge of ERP systems and compliance management tools.

COMPENSATION

$74960 $103070

LOCATION

This role will mainly work out of our B18 Warehouse in Everett WA with occasional travel to our main site in Bothell WA.

Our culture at AGC Biologics is defined by the six core values: Knowledge Trust Quality Ingenuity Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work sidebyside with our clients and partners every step of the way. We provide worldclass development and manufacture of mammalian and microbialbased therapeutic proteins plasmid DNA (pDNA) messenger RNA (mRNA) viral vectors and genetically engineered cells. Our global network spans the U.S. Europe and Asia with cGMPcompliant facilities in Seattle Washington; Boulder and Longmont Colorado; Copenhagen Denmark; Heidelberg Germany; Milan Italy; and Chiba Japan. We currently employ more than 2500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges including specialization in fasttrack projects and rare diseases. AGC Biologics is the partner of choice. To learn more visit.Want to keep posted about our growth and learn more about our company Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age ancestry color family or medical care leave gender identity or expression genetic information marital status medical condition national origin physical or mental disability political affiliation protected veteran status race religion sexual orientation or any other characteristic protected by applicable laws regulations and ordinances.