Analyst III, QC Raw Materials

Emergent BioSolutions; Canton (MA); On-site; USD 84,000 - 102,000; Full time

Job summary

Emergent BioSolutions in Canton, MA is seeking a QC scientist to perform methods and procedures for inspecting, testing, and evaluating raw materials. The role supports SOP improvements, new test methods, and raw material qualification, aligning procurement activities with other Emergent sites and ensuring compliance with quality systems.

You will work with spectroscopic methods, chromatography, and wet chemistry, enter data into the Lims Lab Vantage system, communicate with contract labs and

Qualifications

• Must meet health and safety requirements and vaccination policies as applicable.
• Bachelor’s Degree in Chemistry or related field with 5+ years experience or Master’s with 3+ years (QC Raw Material).
• Experience with spectroscopic methods, chromatography, and wet chemistry.
• Familiarity with pharmacopeias and monograph testing.
• Follow SOPs and comply with cGMPs; generate SOPs.
• Experience with compendial test methods and instrument analytics.
• Strong technical writing for study protocols and reports.
• Able to execute raw material assays including spectroscopy, wet chemistry, chromatography.
• Experience in pharmaceutical testing environment.
• Good communication with manufacturing, materials, and QA.
• Proficient in Microsoft Office.
• Comprehensive knowledge of GLPs and GMPs.
• Knowledge of laboratory techniques and safety precautions.
• Knowledge of regulatory/industry guidance.

Responsibilities

• Supports the implementation of the raw material program at EMOB.
• Leads revision of existing tests and identifies need for new assays per internal processes and GxP requirements.
• Assess compendial changes; revise assays and develop new ones as applicable.
• Daily sampling and testing of raw materials and cleaning lab activities.
• Work with FTIR, pH, refractometry, UV-VIS, HPLC and GC methods.
• Enter sample and results into Lims Lab Vantage system.
• Coordinate with third parties and other departments.
• Prepare specifications, SOPs, and verification protocols and reports.
• Ship samples and monitor results from contract labs.
• Communicate with raw material manufacturers on testing methodologies.
• Perform data analysis and prepare review-ready results.
• Conduct wet chemistry, chromatographic, and spectroscopic testing.
• Support QC lab operations including calibration and maintenance.
• Lead Periodic Review, OOS, deviations, Change Control and CAPAs.

Skills

Chemistry degree

QC experience

Spectroscopy

Chromatography

Wet chemistry

cGMP knowledge

SOP writing

Regulatory guidance

MS Office

GLPs/GMPs

Education

Bachelor’s Degree in Chemistry or related field

Master’s Degree in Chemistry or related

Tools

HPLC

GC

FTIR

pH measurement

Density meter

AKTA

LIMS Lab Vantage

Job description

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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

Perform methods and procedures for inspecting, testing, and evaluating raw materials. Support program improvements including SOPs, new test methods, improved specifications, raw material qualification program, and alignment of raw material procurement with other Emergent sites. Streamline and improve compliance and efficiency in Quality Control programs and develop, implement, and maintain quality control systems and activities. Conduct out-of-specification and failure investigations, recommend, and implement corrective actions. Responsible for generations, tracking, and completion of quality investigations and compliance records for the QC department.

ESSENTIAL FUNCTIONS

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

• Supports the implementation of the raw material program at EMOB.
• Leads change for revision of existing tests and identifies need for development of new assays in accordance with internal processes and consistent with compendial and GxP requirements, as applicable.
• Assesses compendial changes; leads change for revision of existing assays and identifies need for development of new assays in accordance with internal processes and consistent with compendial and GxP requirements, as applicable.
• Perform daily activities in routine sampling raw materials, testing of raw materials and cleaning lab(weekly/monthly).
• Well versed in a wide variety of analytical and compendial methodologies and techniques such as FTIR, pH measurement, refractometry, density/specific gravity measurement using density meter, UV-VIS, distillation, titrations, AKTA, HPLC and GC.
• Perform entering sample and result of raw materials into Lims Lab Vantage system.
• Communicate and coordinate with third parties and/or other departments.
• Prepares specifications, SOPs, and method verification protocols and reports.
• Ships samples and monitors test results produced by contract testing laboratories
• Communicates with raw material manufacturers to implement testing methodologies at EMOB.
• Perform daily activities in routine sampling raw materials, testing of raw materials and cleaning samples.
• Performs required data analysis, compiles data, and prepares results for review
• Conducts wet chemistry, chromatographic, and spectroscopic testing.
• Perform other duties as assigned in support of QC Laboratory operations such as facilities qualification and routine monitoring testing, as well as QC testing, data reviews, sampling, and maintaining QC laboratory systems, when appropriately trained and qualified.
• Supports raw material testing equipment and instrument qualification, calibration, and preventive maintenance, as assigned.
• Lead Period Review, OOS, deviations, Change Control, and CAPAs; designs and implements corrective action plans to address deficiencies.

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.

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 Degree in Chemistry or closely related scientific discipline with at least 5 years of relevant experience or Master’s Degree with a minimum of 3 years of relevant experience. (Mainly QC Raw Material background)
• Experience with spectroscopic methods, chromatography, and wet chemistry methods.
• Familiarity with global pharmacopeias and monograph testing.
• Ability to follow SOPs and comply with cGMPs; generate SOPs.
• Experience with implementing compendial test methods and performing a variety of analyses including computer-based instrumental analytics.
• Strong technical writing capability; can transfer ideas into scientifically sound and efficient study protocols and reports.
• Requires the ability to execute raw material assay methodologies including spectroscopy, wet chemistry, and chromatography.
• Experience working in a pharmaceutical testing environment.
• Requires good technical writing skills and the ability to effectively communicate with manufacturing, materials management, and quality assurance staff.
• Proficient in Microsoft Office - Word, Excel, PowerPoint.
• Comprehensive knowledge of pharmaceutical GLPs and GMPs.
• Comprehensive knowledge of laboratory techniques and safety precautions.
• Comprehensive knowledge of regulatory/industry guidance.

U.S. Base Pay Ranges and Benefits Information

The estimated annual base salary as a new hire for this position ranges from $84,000 to $101,700. 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.