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Analyst I, QA, Document Control

4 months ago

Baltimore, United States BioSpace, Inc. Full time
Job Details

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.

I. JOB SUMMARY
Provide support of document and records management in Document Control using company procedures and regulations to support GxP activities, including issuing, reconciling, processing, scanning, and archiving records. Conduct system and process training. Monitoring completion of department tasks and training new employees. Providing support during regulatory inspections. Schedule for this position os 11am - 7:30pm Monday through Friday, however hours may 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.

• Support completion of department operational tasks related to record and document lifecycle state to include including issuing, reconciling, processing, scanning, and archiving records
• Ensure documents are available in a timely manner to support the manufacturing schedule
• Provide support during regulatory and internal inspections of Emergent quality systems.
• Assist with the development and on-going maintenance of an electronic document management system.
• Maintain records archives both on-site and at off-site archive facility
• Support internal customers in troubleshooting technical issues related to Document Control
• Develop knowledge related to the electronic document management system
• Other responsibilities as assigned

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

• High school diploma or equivalent
• 1-3 years experience working with documents
• Experience with GmP, FDA regulated industry, and/or electronic document management systems are a plus
• Strong skills with Microsoft Office suite
• Excellent attention to detail
• Ability to effectively communicate (oral and written) with internal customers at all levels of the organization
• Ability to work individually and as part of a team with minimal supervision
• Ability to work on multiple assignments simultaneously and prioritize tasks to meet deadlines

IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

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 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.