Quality Control Associate, Senior LIMS/Stability

AGC Biologics

AGC Biologics

Quality Assurance
Bothell, WA, USA
Posted on Dec 11, 2024

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

As an AGC Biologics Quality Control Associate, Senior / Scientist I, Stability & LIMS you'll play a vital role in the implementation and administration of LabWare v.8 for various functions including Lot and Location Management, Stability Management, Raw Materials, and Environmental Monitoring. In this dynamic position, you'll create and revise QC sample plans and analytical data within LIMS, ensuring accuracy and compliance with standards. You will respond swiftly to urgent manufacturing and QC LIMS issues, review and approve essential documentation, and provide training to new users, fostering a knowledgeable team environment. Additionally, you’ll assist in drafting technical documents, coordinate stability testing schedules, and maintain a stability calendar. Your proactive approach will support troubleshooting and enhancements in LIMS, while your dedication will ensure smooth operations, even during evenings and weekends. If you’re passionate about leveraging technology to optimize laboratory processes and are eager to contribute to a collaborative team, we want to hear from you!

ESSENTIAL JOB DUTIES

Quality Control Associate, Senior

LIMS

  • Assist in the implementation and administration of a Laboratory Information Management System (LIMS LabWare v.8) for Lot Manager, Location Manager, Stability Manager, Raw Materials and Environmental Monitoring
  • Create and revise QC Sample plans in LIMS (Labware v7 and v8).
  • Create and revise LIMS analytical data in LIMS including, QC tests, specifications, Environmental monitoring sites, Raw Materials, CoAs, and stability protocols (Labware v8).
  • Respond to urgent Mfg/QC/QA LIMS issues in a timely fashion.
  • Review and revise Standard Operating Procedures and QC Sample records in regards to LIMS functionality.
  • Review QC sample plans in the Master Production records or ATT documents.
  • Provide training to new LIMS users on functionality.
  • Assist with troubleshooting LIMS issues.
  • Assist with implementing changes/enhancements in LIMS to address CAPAs and CRs.
  • Available to be on call for any urgent LIMS related issues or tasks during evenings/weekends/holidays.

Stability

  • Assists with the creation of stability documents.
  • Maintains the stability calendar.
  • Assists with the scheduling of stability testing.
  • Coordinates stability sample pulls and delivery for testing.
  • Coordinates data compilation and CoA preparation.
  • Assist in drafting technical documents including test methods, validation documents, deviations, and stability reports.
  • Assist with the generation of SOPs related to LIMS and stability.
  • Perform data verification and data entry in LIMS and CoAs.
  • Receives/Ships Stability and other samples for QC testing
  • Reviews Vendor test data

Quality Control Scientist I

LIMS

  • Assist in the implementation and administration of a Laboratory Information Management System (LIMS LabWare v.8) for Lot Manager, Location Manager, Stability Manager, Raw Materials and Environmental Monitoring
  • Create, revise, and approve QC Sample plans in LIMS (Labware v7 and v8).
  • Create, revise, and approve LIMS analytical data in LIMS including, QC tests, specifications, Environmental monitoring sites, Raw Materials, CoAs, and stability protocols (Labware v8).
  • Respond to urgent Mfg/QC/QA LIMS issues in a timely fashion.
  • Review and revise Standard Operating Procedures and QC Sample records in regards to LIMS functionality.
  • Review and approve QC sample plans in the Master Production records or ATT documents.
  • Provide training to new LIMS users on functionality.
  • Assist with troubleshooting LIMS issues.
  • Assist with implementing changes/enhancements in LIMS to address CAPAs and CRs.
  • Available to be on call for any urgent LIMS related issues or tasks during evenings/weekends/holidays.

Stability

  • Assists with the creation of stability documents.
  • Maintains the stability calendar.
  • Assists with the scheduling of stability testing.
  • Coordinates stability sample pulls and delivery for testing.
  • Coordinates data compilation and CoA preparation.
  • Assist in drafting technical documents including test methods, validation documents, deviations, and stability reports.
  • Assist with the generation of SOPs related to LIMS and stability.
  • Perform and approve data verification and data entry in LIMS and CoAs.
  • Receives/Ships Stability and other samples for QC testing
  • Reviews Vendor test data

ESSENTIAL RESPONSIBILITIES

  • Employee will ensure no loss of product or product samples by maintaining necessary GMP equipment.
  • Ensure no impact to production schedule due to on time creation of LIMS sampling plans.
  • Ensure no delay to on time delivery of results to clients by maintaining LIMS Lot management functionality.
  • Ensure Stability pulls are completed and reviewed on time.
  • Ensure Stability packets are completed and CoAs are generated within the timeframe.

KNOWLEDGE, SKILLS & ABILITIES:

  • Experience in a QC environment.
  • Experience with Sample Management, Inventory Controls, and data integrity is preferred.
  • Excellent communication and data management skills
  • Experience with the operation, deployment, and administration of LIMS, electronic laboratory notebook (ELN), or other laboratory software systems is preferred.
  • Ability to understand analytical/technical data.
  • Clear, concise writing skills.
  • Ability to interact constructively with co-workers.
  • 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

Education/Training:

QC Associate Senior

  • Education: BS, in Biochemistry or other Biological Science
  • Experience: Minimum of 4+ years’ experience with Quality Systems in a regulated environment (GMP, GLP, etc.)
  • Experience: Minimum of 3+ years’ experience with LIMS
  • Experience with relevant analytical lab equipment and computers.
  • Experience with laboratory equipment, controlled temperature units, and software systems.

QC Scientist I

  • Education: BS, in Biochemistry or other Biological Science
  • Experience: Minimum of 8+ years’ experience with Quality Systems in a regulated environment (GMP, GLP, etc.)
  • Experience: Minimum of 3+ years’ LIMS administration experience
  • Experience with relevant analytical lab equipment and computers.
  • Experience with laboratory equipment, controlled temperature units, and software systems.

Equivalent education and experience may substitute for stated requirements.

Physical Requirements (US Only):

  • Monday - Friday 0900 - 1700 (nights and weekends on call for emergencies)
  • 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:

$83,920 - $115,390

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.