Quality Systems Associate, Senior

Our purpose is to bring hope to life by enabling life-changing 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

Responsible for activities related to creating implementing and maintaining quality systems. Responsible for ensuring compliance with applicable regulatory guidelines.

ESSENTIAL JOB DUTIES/RESPONSIBILITIES

• Create revise release and retire quality system controlled documents.

• Ensure that the document metadata and properties are correctly configured in QMS and adherence of the controlled documents to the applicable internal requirements.

• Define requirements applicable to the development release and retirement of quality systems controlled documents.

• Create and distribute Annual Product Reviews (APR) for all GMP products manufactured upon disposition in compliance with Client agreements.

• Coordinates preparation for audits (internal external).

• Assist to amend/improve and/or cancel Deviations Change Requests CAPAs or other quality events managed by the group.

• Create procedures related to the QMS processes.

• Assists as SME back up for quality systems.

• Identify report and troubleshoot issues in the QMS or manual processes.

• Assist with training activities associated to the QSM processes.

• Supports or may lead multiple more complex projects/initiatives/work items under broad supervision.

• Analyzes issues and makes decisions based on standardized processes and procedures under close supervision.

• Communicates moderately complex concepts and interacts with others to inform and direct action.

• Acts as a resource for less experienced team members and colleagues.

SKILLS

• Leads others to solve complex problems; uses sophisticated analytical thought to exercise judgment and identify appropriate solutions.

• Explains difficult or sensitive information and works to build consensus and is building a skill set to persuade others.

QUALIFICATIONS

Required:

• BS/BA degree and 8 years of relevant experience or

• Masters Degree and 5 years of relevant experience. Equivalent education and experience may substitute for stated requirements.

SCHEDULE

Monday through Friday 8am-5pm

COMPENSATION

$83920.00 - $115390.00

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 side-by-side with our clients and partners every step of the way. We provide world-class development and manufacture of mammalian and microbial-based 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 cGMP-compliant 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 fast-track 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.