JOB TITLE: REGULATORY DOCUMENT CONTROL SPECIALIST
SCOPE: This position is responsible for organizing and maintaining company documentation to assure it is accurate, up-to-date and readily available to appropriate personnel. The individual will handle filing of all product and operations-related documents and control the revisions and distribution of these documents.
RESPONSIBILITIES:
Organizes and maintains all company documents, including: written procedures, analytical methods, laboratory reports, manufacturing records, and including key financial records
Develops, follows, and updates procedures for filing, controlling, and maintaining completed written and electronic records to ensure corporate compliance with applicable regulatory requirements (both FDA and to ensure financial compliance)
Receives and organizes component documents from various sources for organization into larger, comprehensive regulatory submissions to support company clinical trial goals.
Creates and maintains tracking systems for the completed regulatory submissions and the component document versions that comprise them.
Ensures that logistics and needs for preparing and assembling regulatory filings are communicated to staff and are completed in a timely manner.
Responsible for conducting quality assurance reviews of all documents to be included in submissions prior to filing.
Works with a high degree of independence with limited supervision.
QUALIFICATIONS:
2-5 years demonstrated experience preparing FDA document/submissions and thorough knowledge of FDA regulations and submission filing requirements for INDs, annual reports, etc.
Bachelors degree, preferably in a health sciences field.
Advanced proficiency with electronic file management, word processing and spreadsheet/publication software to accurately generate regulatory documents (i.e. Microsoft Word, Excel, etc.)
Ability to perform and organize databases and searches for scientific literature.
Demonstrated work experience that requires strong attention to detail and ability to work well with others in a team manner to complete projects.
Ability to communicate clearly, both orally and in writing, in English, and write in a clear and understandable scientific manner.
Ability to lift and carry up to 20 pounds.
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JOB TITLE: Cell Manufacturing Technician
RESPONSIBILITIES:
Perform a variety of cell separation techniques required for cell manufacturing operations for human clinical trials.
Performing QC release testing for clinical materials or products.
Accurate and timely completion of production records.
Support pre-clinical research and development projects as needed.
REQUIREMENTS:
B.S. degree in biology, chemistry, medical technology or related field with 0 to 2 years of laboratory experience.
Ability to work a variable schedule in a GMP (good manufacturing practice) or GTP (good tissue practice) environment. Some second and third shift required.
Experience in cell culture, microbiology, or sterile technique desirable.
Experience in flow cytometry desirable.
Enthusiastic with excellent team-work skills.
Detail oriented.
Ability to communicate well orally and in writing.
Excellent computer skills with proficiency in Microsoft word, excel, and power point.
Applicants should send their resume to hr@aldagen.com
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