QA Analyst III

 

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.

1. JOB SUMMARY

The QA Analyst III will perform quality functions on the production floor to support manufacturing activities. Our QA Department provides expertise in problem solving and process improvements. The QA Analyst III will interact with all departments to provide guidance necessary to maintain and improve CGMP compliance at the site. QA Analyst III is will be assisting and supporting preparation, testing, and monitoring of conformance to established quality assurance processes and standards for manufacturing and production. They identify risk and evaluate deficiencies while working with internal departments to appropriately remedy them. They facilitate internal training on quality assurance requirements, processes, and procedures. May perform audits and risk assessments.

1. ESSENTIAL FUNCTIONS

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

 

• Critically review and approve various types of documentation to ensure completeness, accuracy, and compliance including, but not limited to, manufacturing records and Quality Control laboratory data for batch and material releases, specifications, SOPs, validation protocols and summary reports, master plans, deviation investigations, CAPAs, and change controls.
• Exercises good judgment within defined procedures to determine appropriate action for resolution of manufacturing or laboratory issues
• Serves in a decision-making capacity on major document changes, deviations, corrective and preventive actions, change control, and other projects
• Performs in-process audits of manufacturing facilities and processes, including aseptic processes and behavior.
• Reviews routine work orders, return-to services, and other documents to ensure that equipment and utilities are fit for use.
• Network with senior internal and external personnel in own area of expertise.
• Communicates effectively with management project status, issues, and mitigations.
• Assumes responsibilities for assigned tasks including a subset of the activities listed herein.
• Participates in batch release and all quality systems associated with batch release:
  • Review of manufacturing and testing records to ensure compliance to site procedures, regulatory requirements, and product license requirements.
  • Review deviation investigations, including root cause analysis.
  • Supports the development and execution of CAPA plans to address identified deviation root causes or compliance/quality gaps.
  • Coordinates and supports the development and execution of change control plans to ensure compliant implementation of product and/or process changes.

 

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.

 

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

• BA/BS (preferably in an Applied Science) or equivalent work experience
• 3-5 years of CGMP experience
• Prior experience with US and EU pharmaceutical regulations, ISO standards
• Knowledge and application of CGMP principles and working in FDA-regulated environment.
• Critical analytical skills and strong verbal and communication skills
• Ability to work under pressure and analyze processes within scheduled timeframes
• Ability to work independently and in a team setting with minimal supervision.
• Ability to make sound decisions regarding compliance-related issues with minimal supervision.  Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

 

*Requires vaccination against different viruses including Vaccinia virus.

 

 

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