Quality Systems Compliance Specialist I

About AGC Biologics
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, visitwww.agcbio.com. 

SUMMARY: The Quality SystemsCompliance Specialist I is responsible for the investigation and completion of process deviations aimed at identification of root cause, and implementation of correct actions to prevent recurrence.  

PRINCIPAL RESPONSIBLITIES:

• 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.

KNOWLEDGE, SKILLS & ABILITIES:

• 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.
• 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

EDUCATION/EXPERIENCE:

• 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
• Experience with GMP compliance in clinical/commercial manufacturing environment required
• Experience with quality management software (Mastercontrol, Trackwise, etc.) preferred
• Experience with asset management software (Blue Mountain, Maximo, etc) preferred Equivalent education and experience may substitute for stated requirements

COMPENSATION RANGE:

$59,760- $82,170

Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.

Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.

Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company's performance and the Team Member's performance.

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.