Analyst II,QC Micro Job Canton area,Massachusetts USA,Quality Assurance

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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 being daily environmental/utility and microbiology testing, quality systems support, and inter-departmental scientific support. Works on complex and varied problems/projects requiring in depth analysis and interpretation.

Responsibilities

Technical Expertise:
o Has core understanding of applicable compliance/guidance/regulations (ISO, USP, FDA, EU).
o Executes laboratory tests and other lab activities to ensure timely delivery of results to internal and external customers.

Testing includes Sterility, Bioburden, endotoxin (gel clot), growth promotion, biological indicator testing.
o Environmental Monitoring, Utilities and Gas sampling and testing.
o Demonstrates proficiency in moderately complex methods such as microbial identification, Bacteriostasis & Fungistasis, Inhibition/Enhancement,Microbial Limits testing, growth promotion.
o Executes validation studies, obtain and interpret validation data following microbial guidance documents.
o Conducts laboratory investigations, knowledge of RCA tools, CAPAs, and CCRs

Laboratory Support (Including Quality Systems):
o Initiates change and continuous improvement using LEAN practices such as 5S and Kaizen.
o Compiles and analyzes EM/Utility Data and write Quarterly/Annual Reports
o Compiles trend analysis for Metrics as needed, and write associated reports for internal and regulatory.
o Uses GMP and scientific expertise to lead internal (department and site) audit activities.
o Mentor and provide guidance to junior personnel.
o Performs laboratory instrument calibration in accordance with established procedures.
o Independently investigates Microbiology testing and equipment issues, and implements CAPAs and CCRs as appropriate
o Represents QC in vendor relations, including contract support and working with vendors during validation (IOPQ) and calibration.
o Ensure critical QC metrics are consistently met for product turnaround times.

Quality Systems:
o Peer Reviews and Verification of QC data.
o Author/revise and contributes test methods; SOPs; specifications; protocols, technical studies or reports.
o Author laboratory investigations and non-conformance.
o 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 minimal 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 general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

Education, Experience & Skills

Due to the nature of this…

Analyst II, QC Micro