Job description
How will you CONTRIBUTE and GROW?
Position Title: Documentation Compliance Specialist
Location: Plumsteadville, PA (Airgas Therapeutics)
In particular, you will:
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Assist with the development and maintenance of product documentation systems. Assist in the creation and revision of Procedures, Approved Supplier Files, Quality System Manuals, Process Manuals, and Obsolete Files for all documentation.
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Assist in the processing of deviations and change control documentation.
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Assist in the documentation review of batch and control records for SF6, PFP, KINOX, APIs, IDEs, INDs and IRBs.
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Assist in maintaining the Documentation Library for active and inactive documentation.
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Maintain various databases and electronic files to track the status of required document control and approval.
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Facilitate conversion to and maintenance of electronic records. Scan various documents into the Documentation System.
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Maintain and distribute Safety Data Sheets (SDS) as required. Maintain the SDS Master File.
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Maintain the Batch Production Record files. Review for completion of all required areas. File BPR's in a timely and organized fashion
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Provide backup capabilities for all quality systems department functions related to the MIS system, writing and reviewing MIS's, and ensuring 100% correct MIS's are created.
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Participates in projects as needed.
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Maintain a clean, organized and safe environment.
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Complete all training activities successfully and on time.
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Are you a MATCH?
Are you a MATCH?
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Two years of college, preferably business, legal or literary studies, or a minimum of three years of experience in a regulatory role of the quality program in a medical device or pharmaceutical manufacturing operation.
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Familiarity and experience with ISO and FDA Quality System Regulations preferred.
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Typing/word processing skills
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Strong grammar and spelling skills
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Strong proofreading skills and attention to detail
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Strong organizational and communication skills
About Airgas
Airgas, an Air Liquide company, is a leading U.S. supplier of industrial, medical and specialty gases, as well as hardgoods and related products; one of the largest U.S. suppliers of safety products.
Airgas, an Air Liquide company, is a leading U.S. supplier of industrial, medical and specialty gases, as well as hardgoods and related products; one of the largest U.S. suppliers of safety products.
Through the passion and diversity of its 18,000 associates, Airgas fosters a culture of safety, customer success, sustainability and innovation. Airgas associates are empowered to share ideas, take initiative and make decisions.
Airgas is a subsidiary of Air Liquide, a world leader in gases, technologies and services for Industry and Health. Air Liquide is present in 78 countries with approximately 64,500 associates globally.
Airgas is a subsidiary of Air Liquide, a world leader in gases, technologies and services for Industry and Health. Air Liquide is present in 78 countries with approximately 64,500 associates globally.
Join us for a stimulating experience: you'll find a world of learning and development opportunities where inventiveness is at the heart of what we do, in an open, collaborative and respectful environment.
Your differences enhance our performance
At Airgas, we are committed to build a diverse and inclusive workplace that embraces the diversity of our employees, our customers, patients, community stakeholders and cultures across the world.
At Airgas, we are committed to build a diverse and inclusive workplace that embraces the diversity of our employees, our customers, patients, community stakeholders and cultures across the world.
We welcome and consider applications from all qualified applicants, regardless of their race, gender, sexual orientation, religion, disability or any other protected characteristic. We strongly believe a diverse organization opens up opportunities for people to express their talent, both individually and collectively and it helps foster our ability to innovate by living our fundamentals, acting for our success and creating an engaging environment in a changing world.
EOE AA M/F/Vet/Disability
Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, sexual orientation, gender identity, protected veteran status, or disability
EOE AA M/F/Vet/Disability
Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, sexual orientation, gender identity, protected veteran status, or disability
Our Differences make our Performance
At Air Liquide, we are committed to build a diverse and inclusive workplace that embraces the diversity of our employees, our customers, patients, community stakeholders and cultures across the world.
We welcome and consider applications from all qualified applicants, regardless of their background. We strongly believe a diverse organization opens up opportunities for people to express their talent, both individually and collectively and it helps foster our ability to innovate by living our fundamentals, acting for our success and creating an engaging environment in a changing world.
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