Specialist I, Quality Assurance

We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

JOB SUMMARY

The QA Specialist I professional will own and be responsible for the QA On the Floor program, QA work order review/approval program and expansion of CDMO operations at the site. This role involves the training and qualification of new QAPQ team members in BPR review and approval, LIMS, QA On the Floor, and Work order approval. The QA Specialist I will support the APR for ACAM2000 and JE-CV and the RA BLA Annual Report programs at the Emergent Canton, MA site. The Specialist I is a quality SME in LIMS for Product and Raw Material disposition process. Manage and lead projects, own quality records (Deviation/CAPA/Change Control) and support additional work as required. Specialist I will back-up the Specialist II in support to the ARC, and EBSI ACAM2000 meetings. The Specialist I has a dual role of performing the QAPQ daily work and being a leader in the group, who can make independent decisions as it relates to the work and projects.

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 LIMS and 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 RA BLA Annual Report
• Drive Continuous Improvement within QAPQ; Identify and improve system compliance and/or process challenges
• SOP generation, review, and approval
• Train QA team members in Batch Record review, QA On the Floor program, Work Orders, LIMS, Document generation and Raw Material and Product disposition
• Own quality records (Deviation/CAPA/Change Control).
• Must be capable to work independently and strategically to ensure day¬ to-day activities are carried out in support of the business goals
• Interacts with 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.
• Provide support during regulatory and internal inspection activities.

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

• Bachelor’s Degree in Scientific or related fields
• A minimum of five (5) years of cGMP Quality experience
• Product and/or Raw material disposition experience
• Familiar with SAP or similar ERP System
• Batch Record review experience
• Commercial manufacturing experience (Large Molecules) required
• Experience on change control, and Annual Product Review/Product Quality Review (APR/PQR)
• Experienced with US, EU pharmaceutical regulations, and ISO standards
• Knowledge and application of GMP principles
• Solid communication skills: oral, written and listening
• Ability to influence without authority across cross-functional organization
• Must be vaccinated for Smallpox and Japanese Encephalitis to work in this position

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill. 

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.