Specialist I, Quality Assurance

Emergent BioSolutions; Canton (MA); On-site; USD 111,000 - 134,000; Full time

Job summary

Emergent BioSolutions is seeking a Specialist I, Quality Assurance in Canton, MA. The role manages Batch Record Review, Product/Raw Material disposition, and SAP Master Data while supporting APR and complaint programs.

You will provide on-the-floor QC support and lead quality projects to ensure compliance. Requires a Bachelor's in a scientific field and at least 5 years of cGMP QA experience, with strong SAP and regulatory knowledge (US/EU).

Qualifications

• Bachelor’s Degree in Scientific or related fields is required.
• At least five years of cGMP quality experience is required.
• Experience with product and raw material disposition is required.
• Strong SAP Master Data experience is required.
• Batch Record review experience is a must.
• Extensive GMP and regulatory knowledge (US/EU) is essential.
• Excellent communication skills, both written and oral, are essential.

Responsibilities

• Review/Approve Batch Records (APS, Engineering, Development runs) and related docs.
• Disposiiton of Product and Raw Materials and components; SAP MD SME.
• Provide on-the-floor quality oversight and real-time issue resolution with operations.
• Generate data for APR/complaints metrics to improve compliance.
• Create, review, and approve SOPs.
• Own quality records (Deviation/CAPA/Change Control).
• Lead/Support the Complaint program and APR processing.
• Work independently and strategically to support business goals.
• Lead or support continuous improvement projects with cross-functional teams.

Skills

Batch Record Review

SAP Master Data

Deviation/ CAPA/ Change Control

APR/PQR

US/EU Pharma Regulations

GMP Principles

On-the-Floor Manufacturing Support

Communication Skills

Education

Bachelor's Degree in Scientific or related fields

Tools

SAP

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

The Specialist I, Quality Assurance professional will be responsible for managing the quality Batch Record Review process to ensure timely completion of review, approval and closure, training of team members and management of quality binders. Responsible for Product and Raw Material Disposition process, to include coordination with QC for product specifications test results, coordination with Fill Finish site quality, 3rd party Diluent supplier and Supply Chain. In addition, the QA Specialist I will support the manager with the Complaint and APR programs at the Emergent Canton, MA site, manage the Right First Time (RFT) metrics, provide On-the-Floor support to manufacturing and a quality SME of SAP material master data. Manage and lead projects, own quality records (Deviation/CAPA/Change Control) and support additional work as required.

ESSENTIAL FUNCTIONS

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

• Review/Approve of Batch Records (including APS, Engineering and Development runs) and other related documentation.
• Disposition of Product and Raw Materials & components. Quality SME in SAP Master Data
• Manufacturing On-the-Floor support (Quality Oversight, logbook review, solve issues real time with operations personnel, etc.)
• Provide data for functional area metrics for APR and complaints among others with the objective to identify and improve system compliance and/or process challenges
• SOP generation, review and/or approval
• Own quality records (Deviation/CAPA/Change Control).
• Manage and support the Complaint program
• APR generation and approval
• Must be capable to work independently and strategically to ensure day¬ to-day activities are carried out in support of the business goals
• Lead or assist in continuous improvement projects as assigned interacts with senior leadership, direct manager, peers, internal customers, external clients and other cross functional peers across Emergent to gain alignment on sound quality decisions.
• Lead and support additional work as required.

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 Degree in Scientific or related fields
• A minimum of five (5) years of cGMP Quality experience
• Product and Raw material disposition is a must
• Well versed in SAP is a must
• Batch Record review is a must
• Strong Commercial manufacturing experience (Large Molecules) required
• Expertise on change control, complaint management and Annual Product Review/Product Quality Review (APR/PQR) is a must
• Experienced with US, EU pharmaceutical regulations, and ISO standards
• Expert Knowledge and application of GMP principles
• Excellent communication skills: oral, written and listening
• Ability to influence without authority across cross-functional organization

U.S. Base Pay Ranges and Benefits Information

The estimated annual base salary as a new hire for this position ranges from $111,000 to $134,400 . 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.