QA Document Control Manager

QA Document Control Manager

Job ID: req4217
Employee Type: exempt full-time
Division: Vaccine Clinical Materials Program
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and 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

• Oversees generation and review of documents used in good manufacturing practices.
• May lead investigations and resolve potential product quality issues to improve efficiency.
• Selects, develops and evaluates personnel to ensure the efficient operation of the function.
• Supervise at least five (5) QA Document Control (QADC) staff, assigning tasks and ensuring workload is distributed evenly across the group.
• Conduct employee performance reviews and approve employee leave and timesheets.
• Write and revise Standard Operating Procedures (SOPs) for process improvements.
• Manage the electronic document review and approval process.
• Participate in audits as required.
• Draft and provide QADC reports to QA management as needed.
• Train staff on QADC procedures.
• Oversees the routing of documents for biennial review.
• Oversees the routing of GMP documents for review and approval.
• Oversees the issuance and reconciliation of GMP controlled documents.
• Oversees the retention and shipment of documentation for offsite storage.
• Review change control and deviations as needed.
• Interface with VCMP departments (e.g., Quality Control, Quality Assurance, Materials Management, Facilities) to provide document control support.
• Participate in meetings and interact with the client to support document control activities as required.
• Interact with senior management.

BASIC QUALIFICATIONS

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

• Possession of a Bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a related field (Qualifying experience (4 years) in Quality Assurance Document Control may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
• In addition to the education requirement, must have four (4) years experience including two (2) years as a manager.
• Must possess basic Microsoft Office skills.
• Complete understanding of controlled documentation to include understanding and navigating complex file structures.
• Ability to write and follow standard operating procedures.
• Ability to interact with senior management.
• Experience with quality systems compliant with FDA regulations for cGMP.
• Experience with an Electronic Document Management System (EDMS).
• Experience with issuing controlled GMP documentation (e.g., batch records, test records, validation field copies).
• Experience with GMP documentation to support phase I/II clinical trials.
• Experience with training staff on document control procedures.
• 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:

• Working knowledge GMP quality systems
• Excellent oral and written communication skills.
• Ability to effectively diagnose problems and confidently explain to management while offering a compliant solution.
• Ability to exercise judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, 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.

109,600.00 - 188,250.00

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.

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The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions