QA Document Coordinator/Processor II
Job ID: req4298
Employee Type: nonexempt full-time
Division: Clinical Research Program
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 USA
The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.
Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.
PROGRAM DESCRIPTION
The Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its' mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.
KEY ROLES/RESPONSIBILITIES
- Performs operational duties in support of regulatory, security, and industry practices compliance documentation.
- Coordinates the verification, approval, and processing of document revisions, and tracks document activity to ensure timeliness and process efficiency.
- Receive, scan, sort, and file documentation according to the organizational filing system (electronic and paper-based).
- Develop and maintain electronic and paper file structures.
- Use and understand the electronic document management system (eDMS) to file/retrieve electronic documentation.
- Format and route documentation for review and/or approval via the electronic workflow process or paper-based system.
- Provide access to documentation for employees.
- Prepare documentation to be shipped to the off-site storage vendor.
- Support the day-to-day activities of the document control group, such as copying, printing, and setting up folders for filing documentation in the record centers
- Create logbooks.
- Assist in the revision of standard operating procedures (SOPs).
- Issue and reconcile GMP controlled documents (e.g., equipment field copies, etc.).
- Track and reconcile documentation via logbooks and Excel spreadsheets.
- Route documentation to the client for review and approval via SharePoint
BASIC QUALIFICATIONS
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
- Possession of a high school diploma or equivalent. Foreign degrees must be evaluated for U.S. equivalency.
- Two (2) years related experience including one (1) year at the level of Administrative Coordinator I or Document Coordinator/Processor I.
- Must possess basic Microsoft Office skills.
- Ability to understand and navigate complex file structures and set up and maintain filing systems.
- Ability to operate a variety of office equipment (e.g. computer, fax, scanner, copier, printer).
- Knowledge of common office practices and procedures: typing, filing, scanning, English grammar, punctuation, spelling, and abbreviations.
- Ability to use an electronic document management system.
- Ability to obtain and maintain a security clearance
PHYSICAL QUALIFICATIONS
- Physical requirements include the ability to maintain balance at all times, walk, kneel, hear (corrective appliance allowed), use of both hands, arms and legs (prosthetic allowed, reach above shoulders, climb ladders, push/pull, repeated bending and stand for extended periods.
- Ability to respond to verbal instruction and cues in a sterile environment where staff are wearing face masks.
- Ability to wear Personal Protective Equipment (PPE).
- Ability to Enter a Laboratory or Encounter a Hazardous Area.
- Visual acuity to include depth perception and vision correctable to 20/40.
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration:
- Previous experience as a document coordinator, secretary, or in an administrative role.
- An understanding of controlled documentation.
- Previous experience in a regulated environment (GCP, GLP, GMP, etc.).
Commitment to Non-Discrimination
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.
Pay and Benefits
Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here
36,000.00 - 61,875.00
The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.
The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions