Analyst II, QC Analytical

Job Summary

This is a laboratory testing position with the major responsibilities include daily testing per SOP, protocol-driven non-routine testing, peer data review, writing/revising standard operating procedures, scheduling lab activities, investigating aberrances and providing/implementing compliant solutions, technical writing, and general laboratory maintenance and upkeep.

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Has core understanding of applicable compliance/guidance/regulations (ISO, USP, FDA, EU).
• Demonstrates proficiency in moderately complex methods such as ELISA, Cell Culture, Plaque assays, CCIT, KF, pH, etc.
• Executes laboratory tests and other lab activities to ensure timely delivery of results to internal and external customers.
• Work with Management to coordinate scheduling of laboratory activities
• Ability to investigate and determine Root Cause associated with laboratory deviations.
• Executes Change Controls, CAPAs, and Effectiveness Checks
• Executes validation studies; obtain and interpret validation data.
• Maintains laboratory equipment as per established procedure.

• Initiates change and continuous improvement using LEAN practices such as 5S and Kaizen.
• Works with facilities/metrology to conduct and document execution of work orders to ensure GMP compliant state of labs and equipment.
• Uses GMP and scientific expertise to lead internal (department and site) audit activities.
• Performs as supporting personnel and/or acts as lead under guidance of management or higher level scientific personnel.
• May provide guidance to lower level personnel.
• Performs laboratory instrument calibration in accordance with established procedures.
• Represents QC in vendor relations, including contract support and working with vendors during validation (IOPQ) and calibration.
• May perform scheduling to ensure critical QC metrics are consistently met for product turnaround times.

• Reviews and verifies QC data.
• Author/revise and contributes test methods; SOPs; specifications; protocols, technical studies or reports.
• Author laboratory investigations and non-conformance.
• Supports CAPA and change control through participation in project planning and collaboration.

• Works on problems of diverse scope requiring evaluation of identifiable factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Receives no instruction on routine work, general instructions on new assignments.

• Ownership – Actively participate in self-development
• Accountability – Follow through on commitments, Situational Leadership or additional accountability tools
• Detail oriented – Able to complete required tasks and associated documentation with minimal error
• Adaptability – Maintain positive attitude in a changing work environment
• Communication – Effectively communicate with all levels of manufacturing and support staff
• Escalate issues through the proper channels
• Live the Core Values

• Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company’s vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.
• Bachelors or Master’s degree in a scientific discipline
• Minimum of 5 years of related experience
• Hands‑on experience with one or more assays and instruments: cell‑based toxin neutralization assays, animal handling and dosing, and cell culture
• Strong technical and communication skills: oral/written and listening
• Personal
  
  Competencies:
  
  Self‑awareness, Integrity, Team Player, Creative, and Flexible.
• Computer skills (MS Office, JMP statistical software, Visio, MS Project)

The estimated annual base salary as a new hire for this position ranges from…