Analyst L, QA Document Control

4 weeks ago

Baltimore, United States Emergent Biosolutions Full time

Analyst I, QA, Document Control

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.

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 mínimal 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.
- Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions._

Pay: $29.00 - $39.00 per hour

**Benefits**:

- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance

Schedule:

- 8 hour shift
- Day shift
- Monday to Friday

**Experience**:

- Microsoft Office: 1 year (preferred)

Ability to Commute:

- Baltimore, MD 21230 (required)

Work Location: In person

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