Specialist I, Quality Assurance

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

Benefits offered by this job

Benefits package

Job summary

Emergent BioSolutions in Canton, MA is seeking a Specialist I, Quality Assurance to manage Batch Record Review, disposition of product and raw materials, and support APR/Complaint programs.

You will lead quality records (Deviation/CAPA/Change Control), support manufacturing on the floor, and collaborate across QA, QC, and Supply Chain to ensure GMP compliance.

Qualifications

• Degree in a scientific or related field.
• Experience with Batch Record review under cGMP.

Responsibilities

• Review/Approve Batch Records and related documentation.
• Disposi tion of Product and Raw Materials; SAP master data SME.
• Provide floor support to manufacturing for quality oversight.
• Generate data for APR and complaints metrics and ensure compliance.
• Lead or participate in SOPs, Deviations, CAPAs, and Change Controls.
• Assist in continuous improvement initiatives and coordinate with cross-functional teams.

Skills

Batch Record Review

SAP Master Data

GMP Compliance

Change Control

APR/PQR

cGMP Quality

Quality Oversight

Cross-functional Influence

Education

Bachelor's Degree in Scientific or related fields

Tools

SAP

Job description

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.

Additionally, Emergent offers a comprehensive benefits package* Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent

(*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.