Analyst II, QC Analytical (Limited Term)

Emergent Biosolutions • Canton, MA

2d • $70,500 - $85,200

About The Position

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.

Requirements

• 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)

Nice To Haves

• 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 Change Controls, CAPAs, and Effectiveness Checks
• Executes validation studies; obtain and interpret validation data.
• Initiates change and continuous improvement using LEAN practices such as 5S and Kaizen.
• Uses GMP and scientific expertise to lead internal (department and site) audit activities.
• May provide guidance to lower level personnel.
• 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.
• Author laboratory investigations and non-conformance.
• Supports CAPA and change control through participation in project planning and collaboration.

Responsibilities

• 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.
• Actively participate in self-development
• Follow through on commitments, Situational Leadership or additional accountability tools
• Able to complete required tasks and associated documentation with minimal error
• Maintain positive attitude in a changing work environment
• 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

Benefits

• Eligibility for additional incentive compensation, including merit increases, annual bonus, and/or long-term incentives in the form of stock options.
• Comprehensive benefits package

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree