Quality Control Associate, Senior LIMS/Stability

Agc Biologics • Bothell, WA

398d • $83,920 - $115,390

About The Position

The Quality Control Associate, Senior LIMS/Stability position at AGC Biologics is crucial for the implementation and administration of the LabWare v.8 Laboratory Information Management System (LIMS). This role involves managing various functions such as Lot and Location Management, Stability Management, and Environmental Monitoring. The associate will ensure compliance with quality standards, respond to urgent issues, provide training, and assist in drafting technical documents, all while maintaining a collaborative team environment.

Requirements

• Bachelor's degree in Biochemistry or other Biological Science.
• Minimum of 4+ years' experience with Quality Systems in a regulated environment (GMP, GLP, etc.) for QC Associate Senior.
• Minimum of 3+ years' experience with LIMS for QC Associate Senior.
• Minimum of 8+ years' experience with Quality Systems in a regulated environment (GMP, GLP, etc.) for QC Scientist I.
• Minimum of 3+ years' LIMS administration experience for QC Scientist I.
• Experience with relevant analytical lab equipment and computers.

Nice To Haves

• Experience in a QC environment.
• Experience with Sample Management, Inventory Controls, and data integrity.
• Excellent communication and data management skills.
• Ability to understand analytical/technical data.
• Strong oral and written communication skills.

Responsibilities

• Assist in the implementation and administration of LabWare v.8 for various functions including Lot and Location Management, Stability Management, Raw Materials, and Environmental Monitoring.
• Create and revise QC sample plans and analytical data within LIMS, ensuring accuracy and compliance with standards.
• Respond swiftly to urgent manufacturing and QC LIMS issues.
• Review and approve essential documentation related to LIMS functionality.
• Provide training to new users on LIMS functionality.
• Assist in drafting technical documents, including test methods and stability reports.
• Maintain a stability calendar and coordinate stability testing schedules.
• Perform data verification and data entry in LIMS and CoAs.
• Receive and ship stability and other samples for QC testing.

Benefits

• Highly competitive compensation package
• Collaborative culture that values personal initiative and professional achievement

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Associate degree
• Number of Employees: 1,001-5,000 employees