Analyst II, QA, Document Control Job at Emergent Biosolutions, Baltimore, MD

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  • Emergent Biosolutions
  • Baltimore, MD

Job Description

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 training, document and records management in Document Control & Training department using company procedures and regulations to support GxP activities. For Training, the role will ensure accurate data entry and creation of learning activities within the site's learning management system while within Document control, the role includes issuing, reconciling, processing, scanning, and archiving records. Other functions include conducting 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.
•Process routine requests to build, update, and assign training within the Learning Management System.
•Ensure that training activities are properly documented and maintain records and files.
•Schedule training activities and coordinates the availability and readiness of training venues.
•Assess new and existing training material to ensure user and company needs are met.
•Support the design and development of classroom, eLearning, and skills assessment.
•training material based on user requirements.
•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.
•Participate on response teams to address observations and recommendations made during internal audits and inspections.
•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
•BS degree (preferred) or equivalent level of skill and experience.
•1-3 years' experience working with documents within a regulated industry.
•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.

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 actions-whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community-we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES
  • Lead with Integrity
    • We gain trust and confidence through ethics, quality, and compliance excellence
  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.

Job Tags

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