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Posted: Monday, January 8, 2018 3:45 AM

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 quality systems for the CGMP operation of Emergent BioSolutions in Baltimore Camden Site. The QA Analyst will perform Batch Release functions. 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.

II: Responsibilities

Key Duties will include:

Batch Review and Release

* QA on the Floor for QC and Micro labs

* Critically reviews executed batch records

* Review of WFI testing data

* Perform SAP Transactions

* Post release batch data entry

* Review of documentation and authorization of shipments

* Review and filling of Ancillary forms

* Facilities Chart review

* Scanning and filling of released batch records

* Assist in non conformance writing and investigations

* Revise SOPs in eDocs

* Perform internal audits according to schedule

* Review and understand analytical data.

* Reviews GMP documents such as batch records, logbooks, and reports.

* Demonstrate strong organization skills related to priorities and work load. Ability to solve problems independently and within a team environment.

Quality System Support

* Author and execute tasks for document revisions, non-conformances, CAPAs, and change controls related to Document Control quality system performance.

* Compile and report performance metrics for Document Control quality systems.

Continuous Improvement

* Coordinate and lead department 6S activities.

* Identify opportunities for improvement within scope of work.

* Educate department personnel on lean concepts.

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 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: Education, Experience & Skills

* BS degree in Chemistry/Biology or related discipline preferred with 4 years Quality Control or Quality Assurance experience.

* MS degree in Chemistry/Biology or related discipline with at least 2 years Quality Assurance experience.

* Minimum of 1 year in an FDA regulated industry.

* 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.

* Proficient knowledge of CGMP.

* Ability to make sound decisions regarding compliance-related issues with moderate supervision.

* Strong leadership skills; high level of personal/departmental accountability and responsibility.

IV: Physical/Mental Requirements

Type/keyboard, stand, walk, sit. Use phone, fax, copier, and computer. Organize/coordinate, analyze/interpret, problem solve, make decisions, supervise, plan, communicate, prepare written communications, and prepare transaction documents. A high percentage of work time is spent in a warehouse where temperatures are cool and noise level can be moderate to high. Most all the time will be spent in the manufacturing rooms where gowning is required.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by 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 .

\"UNDER MARYLAND LAW, AN EMPLOYER MAY NO REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT INDIVIDUALS SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILIAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.\"

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.

SDL2017


Associated topics: prevent, prevention, quality, quality assurance, quality assurance engineer, software quality assurance, software quality engineer, software quality assurance engineer, test, test engineer

Source: http://www.jobs2careers.com/click.php?id=4725773123.96


• Location: Baltimore

• Post ID: 29850152 baltimore
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