Analyst II, QC Analytical; Limited Term

Analyst II, QC Analytical (Limited Term)

Location:

Canton, MA, US, 02021 Canton, MA, US, 02021

Preparedness today, safer tomorrow.

Emergent is a leading public health company that delivers protective and life-saving solutions to
communities around the world. Here, you will join passionate professionals where our culture is informed
by our values and commitment to protecting and saving lives.

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.

This is a limited-term position expected to last approximately 12 months. Employment is anticipated to conclude at the end of the assignment, subject to business needs.

Job Responsibilities

Technical Expertise:

• 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

Laboratory Support (Including Quality Systems):

• 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.
• Quality Systems:
  • 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.

Problem Solving:

• 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.

Behavior/Cultural Responsibilities:

• 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
• Actively participate in department / level meetings
• Escalate issues through the proper channels
• Live the Core Values

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all…