Analyst II, QC Raw Materials

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

Job summary

Emergent BioSolutions is seeking an on-site laboratory position in Canton, MA to perform daily testing, support quality systems, and provide inter-departmental scientific support. The role involves working on complex problems requiring in-depth analysis and interpretation, ensuring timely delivery of results to internal and external customers.

The position requires understanding of GMP, ISO, USP guidelines, hands-on experience with LIMS, and proficiency in wet chemistry techniques.

Qualifications

• Bachelor’s or master’s degree in an applied science (chemistry preferred).
• 3 - 5 years of experience preferred, or equivalent level of skill and experience.
• An understanding of cGMP, CFR, and USP is required.
• Good written and verbal communication skills; teamwork skills.

Responsibilities

• Sample, label, test, send for external testing, and release of incoming raw materials using LIMS.
• Support laboratory through maintenance of laboratory, equipment, and test methods per procedures.
• Own and drive: quality notifications and tasks in the quality management system (deviations, CAPA, Change Controls, Effectiveness Checks).
• Perform material qualification tasks (testing, report generation).

Skills

Health and safety

cGMP CFR USP

Laboratory techniques

Documentation

Communication skills

MS Excel

Education

Bachelor or Master in Applied Science (Chemistry preferred)

Tools

LIMS

HPLC

FTIR

UV-Vis

Titration

Job description

Select how often (in days) to receive an alert:

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 an on-site laboratory testing position with the major responsibilities being daily testing, quality systems support, and inter‑departmental scientific support. Works on complex and varied problems/projects requiring in depth analysis and interpretation.

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

Overview:

• Sample, label, test, send for external testing, and release of incoming raw materials utilizing LIMS.
• Support laboratory through the maintenance of laboratory, equipment, and test methods per approved procedures.
• Own and drive to completion:
  • quality notifications and tasks in the quality management system (deviations, CAPA, Change Controls, Effectiveness Checks)
    creation of new documents and document updates
  • Performance of material qualification tasks (testing, report generation)

Technical Expertise:

• Has understanding of applicable compliance/guidance/regulations (ISO, USP, FDA, EU).
• Demonstrates proficiency in simple methods such as physical inspection, pH, dimensional analysis and appearance and moderately complex methods such as FTIR, Titration, UV Vis
• Spectrophotometry, Gel Electrophoresis, HPLC, and Loss on Drying.
• Ability to follow written procedures and execute laboratory methods including wet chemistry techniques.
• Experience using LIMS to manage samples and document testing results.
• Executes laboratory tests and other lab activities to ensure timely delivery of results to internal and external customers.
• 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.
• Follows good laboratory practices and procedures in analyzing situations or data from which answers can be readily obtained
• 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 staffli>
• 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 management’s right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

MINIMUM 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.
• Bachelor’s or master’s degree in an applied science (chemistry preferred).
• 3 - 5 years of experience preferred, or equivalent level of skill and experience.
• Previous hands‑on experience with Raw Material assays in a GMP manufacturing environment is preferred.
• Personal Competencies: self‑awareness, integrity, team player, innovative, and flexible.
• An understanding of cGMP, CFR, and USP is required.
• Require good written and verbal communication skills, good teamwork skills
• Computer skills (MS Office, MS Excel, MS Project) or comparable word‑processing and spreadsheet applications is required.

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.