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QA – Document Control
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Organizational Unit: Quality Assurance
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Scope of Position:
The QA Specialist position facilitates system-wide compliance of VIRxSYS to federal regulations promulgated by the FDA under 21 CFR Part 210 and 211 [current Good Manufacturing Practice regulations (cGMP)]. Additionally, the QA Specialist is responsible for assisting in the development and implementation of QA systems and procedures. Where applicable, the QA Specialist supports clinical trial activities.
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Major Responsibilities:
· Provide Good Manufacturing Practices (GMP) documentation support for Manufacturing, Quality, and other departments within VIRxSYS.
o Ensure that only current, approved procedures are utilized company-wide.
o Issue controlled working documentation for use in manufacturing, QC testing, labeling and packaging of clinical material.
· Ensure that VIRxSYS document management systems for control of policies, procedures, and development and production records are compliant with current FDA regulations.
o Coordinate the timely review, revision, approval and issuance of Standard Operating Procedures (SOP’s), Batch Records, Test Procedures, and other records.
o Write and revise SOP’s related to Documentation Control system policies and procedures.
o Ensure that documents submitted to QA Document Control are logically structured and follow established document templates.
o Ensure the security and integrity of Document Control Systems (electronic databases, electronic documents and records).
· Review basic QC procedures such as blood processing, DNA quantitation by PicoGreen, and nucleic acid extractions.
· Assign deviation numbers and maintain the Deviation Log.
· Review, approval and release of GMP raw materials.
· Develop cGMP and QA training materials, as applicable. Provide employee training. Maintain employee training files.
· Perform other duties as required.
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Experience and Qualifications Requisite for Position:
· Experience working in a biotechnology, pharmaceutical, diagnostics and/or medical device company is desired.
· Knowledge of cGMPs, quality systems, and other FDA regulatory guidelines for drugs and biologics is desired.
· Demonstrated ability to work affectively, follow instructions, maintain schedules/timelines, and manage multiple priorities.
· Knowledge of applicable software, i.e. Microsoft (MS) Word, MS Excel, MS Access and Adobe Acrobat.
· Ability to organize and manage large quantities of documentation.
· Detail oriented, good oral and written communication skills.
· Ability to generate reports demonstrating a good command of grammar and punctuation.
· Ability to work with others in a team-oriented and goal-oriented environment.
· Ability to create spreadsheets, databases, etc. for capture of pertinent data.
Educational Requirements:
· Bachelor’s Degree in a biological science is preferable with at least 1-2 years experience in a GMP environment.
If you qualify, let us know by e-mailing your CV and references to: E-mail: employment@virxsys.com.
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