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Analyst III, Quality Assurance, Shop Floor

Location: 

Baltimore (Bayview), MD, US, 21224


 

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

I: JOB SUMMARY

The Analyst III, Quality Assurance is responsible for 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. This responsibility should include at least three of the following systems in support of product manufacturing at Emergent Manufacturing Operations Baltimore (EMOB):

- Supplier Quality - Compliance
- Product and Material Release - Quality Systems
- Documentation Control - Training


II: ESSENTIAL JOB 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
• Resolves a wide range of issues in creative ways. Defines appropriate actions and
 

requirements for resolution of issues
• Demonstrate good judgement in selecting method and techniques for obtaining solutions
• 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
• Supplier Quality Oversight
• Supplier change notification impact assessment and implementation
• Liaise with suppliers in addressing nonconformities through thorough investigations. Assess and determine appropriateness of corrective/preventive actions to avoid recurrence

• Plan, schedule, and conduct internal and external (supplier) quality system audits per audit schedule. This includes a review of prior internal audits and regulatory inspections, reviewing procedures, processes, and activities in creating the audit plan
• Lead or participate in inspection readiness plans and activities and serve as subject matter expert in quality systems
• Conduct regulatory surveillance to maintain current regulatory expectations and devise and provide GXP training to the facility

Product & Material Release
• Independently review and perform disposition of raw materials, components, bulk drug substance, and final drug substance
• Liaise with contract manufacturers responsible for filling, inspection, labeling, and packaging of product by providing Quality oversight for deviations, change controls, and other quality systems that may impact EMOB’s products
• Assist with the oversight of Support the reference and retention programs

Quality Systems
• Maintain Emergent’s Quality Systems including, but not limited to, Deviations, CAPAs, Change Control, and Management Review in support of manufacturing operations
• Lead or participate in cross-functional teams to address facility issues using methodical problem-solving tools in analyzing the issues, determination of root cause, identification
of appropriate corrective and preventive actions, and assessment of impact to product
 
• Prepare functional and Management Review metrics for identification of negative trends. Conduct analysis of identified negative trends and propose/implement necessary corrections to address and present to Management team

Documentation Control
• Serve as primary liaison between EDMS Global Administrator and Baltimore’s EDMS users to maintain EDMS functionality and perform administrative activities for the applicable software
• Serve as technical expert to assist and provide support to end users. Provides EMDS users with Level appropriate training as required and maintains EDMS training materials
• Ensure document lifecycle from generation of document to archival

Training
• Assist in managing New Employee Orientation program
• Assist in maintaining Training Program including identification of training needs for the facility and maintenance of Site training curricula
• Serve as a liaison between LMS Global Administrator and Baltimore’s LMS users to maintain LMS functionality and perform administrative activities for the applicable software

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.


III: MINIMUM EXPERIENCE, EDUCATION, SKILLS
 Bachelor’s Degree in Scientific or related fields

    Minimum of five (5) years of cGMP Quality experience
 Strong Commercial manufacturing experience (Large Molecules)
 Quality Auditor, Six Sigma, or equivalent certification/education preferred
 Prior experience with US, EU and Canadian pharmaceutical regulations, ISO standards
 Knowledge and application of GMP principles, and working in an FDA regulated environment
 Strong communication skills: oral/written and listening
 Strong facilitation skills
 Experienced in developing and delivering technical/classroom training
 Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability
 Interpersonal skills: team building, consensus building, conflict resolution
 Critical analytical skills, strong verbal and communication skills
 

 Ability to work under pressure and analyze processes within scheduled timeframes
 Ability to work independently in conducting quality system and process audits.
 Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio.
 Excellent presentation skills, including written and verbal communication skills
 Ability to travel (10%)


IV: PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.

The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.

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

Type/keyboard, visual acuity, stand, walk, sit, squat/kneel, sense of hearing, and lift/carry 15 lbs. Use phone, fax, copier and computer. Organize/coordinate, analyze/interpret, problem solve, make decisions, supervise, plan, communicate and prepare written communications.

 

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

 

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

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

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

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.


Nearest Major Market: Baltimore