Analyst II, 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 Analyst II is responsible for Site and CDMO Batch Production and Solution Prep Record review, raw material and product disposition, and work order pre and post approval. Support the QA On the Floor program providing observations of the manufacturing process, logbook review, NPA inspections, NPA cleaning observations and logbook review. The QA Analyst will also support document reviews in Veeva, own QMS records (Deviations, CAPA, Change Controls) and support  investigations relating to Product Complaints. Support to team and site metrics, Tier Boards, APR batch lot data and other projects as needed.

ESSENTIAL FUNCTIONS

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

•            Review/Approval process of Batch Records (including APS, Engineering and Development runs, and SPRs)

•            Perform lot disposition process of lots in Canton, MA (i.e. drug substance, APS, and Diluent for ACAM2000)

•            Responsible for the Disposition of Raw Materials and components. Evaluate raw material documentation to ensure completeness, accuracy and compliance with Emergent material specifications and SOPs, including Final Quality Assurance approval.

•            Support the WO QA assessment process in Canton, MA

•            Shop floor support (Quality Oversight, logbook review, solve issues real time with operations personnel, etc.)

•            Own QMS records (Deviations, CAPA, Change Control) as required.

•            QA review and approve GMP documents (SOP, BPR, SPR, SPE, Stability Reports) in EDMS (VEEVA)

•            Support Regulatory Inspections/Audits by providing documentation to fulfill requests for information and participating in the audit or inspection as requested.

•            Own/Support OE and 8 Waste projects as assigned 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

• Associates/Bachelor’s degree is life sciences or equivalent.
• Minimum of 2 years of experience in pharmaceutical manufacturing, biologics, vaccines or equivalent
• Ability to work independently and in a team setting.
• Solid organizational, analytical and problem-solving skills.
• The ability to coordinate multiple priorities in a fast-paced environment.
• Knowledge and application of GMP principles
• Familiar with SAP or similar ERP System
• Batch Record review experience
• Solid communication skills: oral, written and listening.
• Ability to influence without authority across cross-functional organization
• Must be vaccinated against 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.