QC Analyst II: 12-Month Lab Role

Emergent BioSolutions; Canton (MA); Hybrid; USD 71,000 - 85,000; Full time

Job summary

Emergent BioSolutions is seeking an Analyst II, QC Analytical (Limited Term) in Canton, MA. The role involves daily testing per SOP, non-routine testing, data review, SOP revision, and lab coordination in a GMP environment.

The position is limited-term for about 12 months, with responsibilities spanning ELISA, Cell Culture, and routine lab maintenance, aligned with LEAN and continuous improvement practices.

Qualifications

• 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.

Responsibilities

• Execute laboratory tests and other lab activities to ensure timely delivery of results to internal and external customers.
• Investigates aberrances and provides compliant solutions; writes/revises SOPs and technical studies.
• Executes Change Controls, CAPAs, and Effectiveness Checks; maintains laboratory equipment.
• Supports GMP compliant state of labs and equipment with facilities/metrology coordination.
• Reviews and Verifies QC data and contributes test methods; supports CAPA and change control.

Skills

ELISA

Cell Culture

Plaque Assays

GMP

Education

Bachelor's or Master's in a scientific discipline

Job description

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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 duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

Education, Experience & Skills

• 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)

U.S. Base Pay Ranges and Benefits Information

The estimated annual base salary as a new hire for this position ranges from $70,500 to $85,200. . Individual base pay depends on various factors such as applicant’s education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant’s geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.]

(*Eligibility for benefits is governed by the applicable plan documents and policies).

If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

ABOUT EMERGENT

Emergent prepares those entrusted with protecting their communities against current and future health threats.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

• Lead with Integrity
  • We gain trust and confidence through ethics, quality, and compliance excellence
• Stand shoulder to shoulder
  • We combine our best thinking and communicate openly to support each other.
• Own it always
  • We are engaged and accountable for delivering on our commitments.
• Breakthrough thinking
  • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
• Compete where it counts
  • We set the right goals and respect each other as we conquer them together.