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 Compliance Specialist II is responsible for the investigation and completion of process deviations aimed at identification of root cause, and implementation of correct actions to prevent recurrence.

ESSENTIAL JOB DUTIES/RESPONSIBILITIES

• Perform root cause analysis on manufacturing deviations, serving as primary author of deviation reports

• Utilize technical writing for the educated but uninformed reader, translate moderate to complex scientific events into a brief and cohesive report as a finished product.

• Address comments from both internal and external stakeholders on the final report.

• Lead investigations for manufacturing and bring them to a resolution with minimal direct supervision.

• Gather Data from various sources across the site

• Perform Root Cause Analysis to determine the most likely cause of the deviation investigation

• Assess event for impact to SISQP, perform trending analysis, identify Corrective and Preventative Actions (CAPA) to reduce deviation recurrence, perform Risk Assessments, and Causing Mapping facilitation

• Initiate appropriate corrective action/preventative action (CAPA) to prevent deviation recurrence.

• Work closely with manufacturing operations, QA team, and support groups to develop appropriate CAPAs

• Facilitate and participate in meetings, aligning internal review team and area subject matter experts on an agreed upon investigational path forward.

• Participate in the Daily Management meetings to update leadership on current deviation statuses

• Work with the manufacturing team by going to the production areas for data gathering, observing of processes for investigations, and performance of associate interviews.

LEADERSHIP SKILLS

• Demonstrated ability to manage multiple projects and timelines concurrently.

• Ability to adhere to standard timelines, and escalate actions appropriately for resolution in a timely manner.

• Demonstrated skills in conflict resolution, problem solving in a cross functional setting, with the ability to keep the meeting on track to achieve objective.

• Prior experience technical writing and in a manufacturing environment preferred

• Must have the ability to work in a fast paced, high workload environment, with the ability to manage multiple projects and objectives for on-time event closure.

• Must work well on a team

• Must be able to trouble shoot and problem solve in a cross functional team setting.

• Must be proactive, action oriented, and have the ability to adapt to change.

• Must be able to identify and flag risks in a timely manner to keep deliverables on track.

• Strong written and verbal communication skills are required.

QUALIFICATIONS

Required:

• BS in scientific discipline such as Biochemistry, Chemistry, Biology or related discipline required

• Minimum of 2+ years’ experience conducting investigation and root cause analysis in a pharmaceutical or FDA/GMP environment required

• Equivalent education and experience may substitute for stated requirements

• Ability to read and comprehend complex subjects.

• Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems.

• Ability to understand and apply GMP regulations as they relate to manufacturing

• Experience with GMP compliance in clinical/commercial manufacturing environment required

Preferred:

• Experience with quality management software (MasterControl, Trackwise, etc.) preferred

• Experience with asset management software (Blue Mountain, Maximo, etc) preferred

SCHEDULE
Monday through Friday. 8 AM - 5 PM. On Site.

COMPENSATION
$59,760 - $89,640

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.