1+ months

Analyst III, Quality Assurance Shop Floor (3rd Shift)

Baltimore, MD 21202
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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, Shop Floor is responsible for assisting and supporting Quality Assurance activities in support of Phase I, II, III and commercial manufacturing of biotechnology products. This position is suitable for an employee who has a potential for growth and development in all areas of quality support such as supporting internal/external inspections, investigations, and corrective and preventative actions.The incumbent will interact with external CMO clients, senior leadership, direct manager, peers, internal customers, and other cross functional peers across Emergent to gain alignment on sound quality decisions. This position will support our Bayview site which operates on a 24/7 schedule. Primary work hours will be Monday through Friday from 2:00pm-10:30pm. However, due to the needs of Emergent or departmental needs those hours are subject to change.

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

Support/execute QA on the Floor program to provide quality oversight of manufacturing operations
Work closely with technical, quality, and operational management to address any observations noted during execution
Provide sound quality judgement in a fast-paced scenario, and escalate when needed
Establish good rapport and work closely with manufacturing personnel to help drive a Quality mindset
Support/execute real-time Batch Record review of executed/Master Batch Records on the floor
Support/execute revision and creation of Standard Operating Procedures in document management system
Support internal customers in manufacturing, QC, Engineering and Facilities, Validation, Supply Chain, Procurement, and QA
Support cross functional teams made up of employees at various experience levels and provide input as needed on Quality/compliance issues.
Support the generation of QA operations metrics
Exercise judgment within defined site procedures to determine appropriate action for resolution of technical issues
Receive assignments in the form of objectives to help achieve department goals
Participate in company sponsored training
Support regulatory and client audits
Provide Quality input/support to investigations, CAPAs and changes
Support site inspection readiness strategy and activities
Support internal audits per audit schedule

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 managements assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
BS degree or equivalent years of experience in the field.
Minimum 5 years experience supporting GMP manufacturing; conducting facility/lab walkthroughs, supporting a QA on the Floor Program, releasing raw materials in SAP, identifying compliance risk and gaps, providing Quality input/oversight of potential manufacturing/lab deviations and performing batch record review on executed/master batch records
Preferred experience in biologic drug substance manufacture
Experienced in application of GMP principles, Minimum of 2 years in an FDA or other equivalent regulated industry.
Strong computer skills with the Microsoft Office product line.
Moderate understanding of regulations governing document control and records management.
Ability to effectively communicate (orally and written) with all levels of personnel at multiple company locations.
Experienced with US, EU and Canadian pharmaceutical regulations, ISO standards
Strong communication skills: oral/written and listening
Ability to work individually and in a team environment
Ability to work under pressure and analyze processes within scheduled timeframes
Strong presentation skills, including written and verbal communication skills
Experience in SAP and Technical Writing

IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

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 actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe 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.

Industry

  • Biotechnology
Posted: 2021-11-15 Expires: 2022-05-23

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Analyst III, Quality Assurance Shop Floor (3rd Shift)

Emergent BioSolutions Inc.
Baltimore, MD 21202
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