1+ months

Analyst II, Quality Assurance Batch Release, 2nd 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 QA Analyst II is responsible for performing duties related to the management of records relevant to the review and release of Batch Records for the cGMP operation of Emergent BioSolutions at the Baltimore Camden Site. Our QA Department provides expertise in problem solving and process improvements. The QA Analyst will interact with all departments to provide guidance necessary to maintain and improve cGMP compliance at the company. This position will support or Camden location as a 2nd shift role and will work 2pm-10:30pm Monday through Friday. However, as Camden is a 24x7 location, work hours are subject to change based on the needs of the business.

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

Batch Review and Release

Critically reviews GMP documents such as:
oExecuted batch records for a variety of different functional areas
oAnalytical Testing Data
oMicrobial and Environmental Monitoring Data
oWFI testing data
oEquipment Data
oLogbooks
Perform SAP Transactions
Post release batch data entry
Review of documentation and authorization of shipments
Review and filling of Ancillary forms
Scanning and filling of released batch records
Initiate non-conformance investigations
Demonstrate strong organization skills related to priorities and workload. Ability to solve problems independently and within a team environment.

Quality Operations Support:
Compile and report performance metrics for Batch Review and Release relevant activities.

Continuous Improvement
Identify opportunities for improvement within scope of work.
Participate in operational excellence activities.

Regulatory Inspection
Provide logistical support and technical knowledge during regulatory and internal inspections of Emergent quality systems.

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 in Chemistry/Biology or related discipline with 1-3 years Quality Control or Quality Assurance experience or a MS degree in Chemistry/Biology or related discipline with at least 1-year Quality Assurance experience, preferred.
1 year in an FDA regulated industry is preferred.
Must have strong attention to detail.
Ability to manage multiple priorities and tasks in a dynamic environment.
Excellent written and verbal skills.
Ability to exercise judgment to determine appropriate corrective actions.
Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions.
Ability to use computer programs.
Ability to work in a team environment.
Working knowledge of cGMP.
Ability to make sound decisions regarding compliance-related issues with moderate supervision.

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: 2022-05-22
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Analyst II, Quality Assurance Batch Release, 2nd Shift

Emergent BioSolutions Inc.
Baltimore, MD 21202
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