Quality Assurance Associate III, Regulatory Compliance

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

The QA ASSOCIATE III, REGULATORY COMPLIANCE is responsible for ensuring compliance with internal SOPs and applicable regulatory guidelines and requirements.  This role requires attention to detail, organization, multi-tasking, and ability to interact with people who might be junior or senior to the incumbent.

ESSENTIAL JOB DUTIES/RESPONSIBILITIES

• Support Regulatory Inspection Readiness
• Inspection Preparedness, performing inspection readiness activities
• Maintain inspection readiness through inspection preparedness program and periodic readiness verification
• Execute against plan (training, document readiness, response preparation and readiness)
• Author, Review, and Approve SOPs, company Policies, and other GMP documents
• Support the program to pro-active management of clients to ensure confidence in Quality systems including:
• Establish Quality Agreements with clients consistent with Global standard.
• Ensure communications with client are maintained consistent with Quality Agreement and positive client experience
• Support required client audits and provide observation responses consistent with timeline commitments
• Maintain compliance documentation and licensing
• Establish a calendar to provide visibility to compliance documentation requirements
• Generate and provide required documentation to clients and Regulatory authorities
• Participate and lead Improvement initiatives aimed to add efficiency to the Quality processes.
• Develops and leads large and/or multiple programs, initiatives, and activities for the function or broad organization with moderate resource requirements, risk, and/or complexity.
• Analyzes and evaluates issues and makes decisions within general parameters under little supervision.
• Contributes to development of best practices for functional area.
• Communicates moderately complex concepts and interacts with others to inform and direct action.
• Acts as a resource for less experienced team members and colleagues.

KNOWLEDGE, SKILLS & ABILITIES

• Strong understanding of cGMP’s and concepts in several quality systems.
• Demonstrated knowledge of GMP, GCP and both US and foreign regulations (EU, IPAC, ICH) is required.
• Strong oral and written communication skills.
• Ability to negotiate needed actions and manage difficult interactions effectively.
• Knowledge of computerized support tools and software for audit tracking and reporting.
• Demonstrated knowledge of quality processes and compliance.
• Demonstrated ability to multi-task and work on several projects and problems
• Ability to work under only general direction
• Ability to independently determine and develop approach to solutions

LEADERSHIP SKILLS

• Analyzes multiple sources of information and evaluates several alternative solutions before confirming correct path. 
• Explains complicated information and effectively lays out variations of alternatives to consider. 
• Works across teams effectively. 
• Applies understanding of how the team relates to other closely related areas to improve efficiency of own team. 
• 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 5 years of relevant experience.  Equivalent education and experience may substitute for stated requirements. 
• Equivalent education and experience may substitute for stated requirements

Physical Requirements (US Only):

• While performing the duties of this job, the employee may be regularly required to stand, sit, talk, hear, reach, stoop, kneel, and use hands and fingers to operate a computer, telephone, and keyboard.
• Specific vision abilities required by this job include close vision requirements due to computer work.
• Light to moderate lifting may be required.
• Regular, predictable attendance is required; including quarter-driven hours as business demands dictate.

COMPENSATION RANGE

$74,960.00 - $103,070.00

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 2,500 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 www.agcbio.com.  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.

Salary : $74,960 - $103,070