QA Document Specialist

QA Document Specialist

Job ID: req4273
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

• Support the day-to-day activities of the document control group’s paper documentation (Records Center) and electronic documentation (EDMS).
• Create, copy, and print folders for filing documentation in the Records Center.
• Create and manage electronic documentation in the EDMS.
• Develop and maintain file structures in the Records Center and the EDMS.
• Receive, scan, sort and file documentation according to the Records Center and the EDMS organizational filing systems.
• Provide access to Records Center and EDMS documentation for employees.
• Issue and reconcile GMP controlled documents (production batch records, field copies, validation protocols, etc.).
• Create logbooks.
• Monitor documentation via paper logbooks and electronic spreadsheets.
• Manage the biennial review process of GMP documents (SOPs, SLPs, MPs, etc.).
• Train VCMP staff on EDMS workflows (new hire and refresher training).
• Support other departments in a timely and professional manner.
• Format and route documentation for review and/or approval via EDMS workflows.
• Provide guidance to junior staff on processing documents via EDMS workflows as needed.
• Assist CSV and IT to resolve new EDMS workflow issues.
• Prepare Records Center documentation to be shipped to the off-site storage vendor.
• Assist QADC manager with change controls, deviations, and investigations.
• Implement team projects as an individual, or as coordinator of individual assignments.
• Draft and revise standard operating procedures (SOPs) for process improvements.
• Participate in audits as required.

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• This is a hybrid position requiring onsite work in the office in Frederick, MD and at least four days a week or more as needed.
• Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency.
• Previous experience as a document coordinator, secretary or administrative assistant required.
• Ability to understand and navigate complex file structures and set up and maintain filing systems.
• Ability to operate a variety of office equipment (computer, fax, scanner, copier, printer, etc.).
• Knowledge of common office practices and procedures: typing, filing, scanning, English grammar, punctuation, spelling and abbreviations.
• Experience with the Microsoft Office suite, including but not limited to Word, Outlook, Excel, and Teams
• Professional office skills, including, but not limited to speaking professionally on the phone, professionally communicating via email and in person, working in a group environment, working collaboratively with a partner, and working alone.
• Ability to format and route documentation for review and/or approval via the electronic workflow process or paper-based system.
• Ability to write and/or co-write revisions of standard operating procedures (SOPs).
• An understanding of controlled documentation.
• 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.
• Visual acuity to include depth perception and vision correctable to 20/40.

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Candidates with GCP, GLP or GMP experience OR experience in a highly regulated environment will be given preferred status.
• Previous experience working with browser-based document sharing systems.
• Previous experience writing procedure documents and/or editing documents for publication.

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

47,900.00 - 82,375.00

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