Loading...
 

Analyst II, QA Document Control

Location: 

Gaithersburg, MD, US, 20879


 

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.

The Analyst II is responsible for administering and maintaining controlled documents, records, and the document control system in accordance with company requirements. This position is a key role to ensure product documentation meets defined quality standards and provides guidance to users of the document control processes. 

This role exercises judgment within defined practices and policies in selecting methods and techniques for obtaining solutions; identifies opportunities for improvement within the scope of work; works on problems of moderate scope in which analysis of situations or data requires review of a variety of identifiable factors; and normally receives general instruction on routine work and detailed instructions on new assignments. 

Prefer someone that can work in the Gaithersburg office at least one day a week but can work remote the rest of the week.

 

ESSENTIAL FUNCTIONS
Maintain document control system for controlled documents such as procedures, test methods, protocols, and reports in support of product development and GMP activities. 
• Issue laboratory notebooks, equipment logbooks, batch records, and maintain associated logs. 
• Coordinate the edit, review, approval, and issuance of controlled documents to meet deadlines. 
• Control access to original manual records maintained onsite. 
• Maintain document archival system including the master log of records sent to off-site storage, follow SOPs and/or work instructions and implement process improvements for efficiency gains. 
• Coordinate the submission, storage, retrieval, and retention of records on-site and at off-site storage. 
• Perform periodic review of document retention periods for record destruction. 
• Track and trend various components of document control process such as controlled document deliverables, laboratory notebook issuance, and archival data. 

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. 

 

EDUCATION, EXPERIENCE, SKILLS
•    High school diploma or equivalent required; college coursework preferred 
•    2-5 years' experience in Good Manufacturing Practices, Good Laboratory Practices and/or Good Clinical Practice environment in a Document Control or Quality related role 
•    Good communication and organizational skills, attention to detail, ability to work under pressure and to deadlines, ability to multi-task, and ability to work across all levels of the organization are required 
•    Proficient at MS Office programs including Outlook, Word, Excel and PowerPoint 
•    Strong verbal and written communication skills 
•    Highly motivated to fulfill requests to meet timelines supporting the work of others 
 

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

 

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

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.


Nearest Major Market: Washington DC