Analyst II, QA Document Control, 2nd Shift
- Emergent BioSolutions
- Baltimore, MD
- Start date
- Mar 17, 2023
- Quality, Quality Assurance, Regulatory
- Required Education
- Bachelors Degree
- Position Type
- Full time
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 oversight and support of document and records management in Document Control using company procedures and regulations. Conduct system and process training. Provide 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 issuance and processing
• Ensure documents are available in a timely manner to support the manufacturing schedule
• Maintain records archives both on-site and at off-site archive facility
• Support internal customers in troubleshooting technical issues related to Document Control
• Develop subject-matter expertise related to the electronic document management system
• Maintain and report document control metrics to department and site leadership
• Create and revise applicable SOPs as required
• 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
• Bachelors degree or equivalent level of skill and experience
• 2-4 years related experience
• Experience with electronic document management systems preferred
• Intermediate skills with Microsoft Office suite
• 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.
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.
Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter.
Stock Symbol: EBS
400 Professional Drive
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