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Quality Assurance Specialist - Bethlehem, PA 18015
Praxair
Job
details
Job Type
Full-time
Full Job Description
Quality Assurance Specialist
Praxair, Inc. is a leading industrial gas company in North and South America
and one of the largest worldwide. Praxair produces, sells and distributes
atmospheric, process and specialty gases, and high-performance surface
coatings. Our products, services and technologies are making our
planet more productive by bringing efficiency and environmental
benefits to a wide variety of industries, including aerospace, chemicals,
food and beverage, electronics, energy, healthcare, manufacturing, primary
metals and many others. For more information about the company, please visit
our website at www.praxair.com.
Praxair Distribution, Inc. is seeking a Quality Assurance
Specialist to join our team located in Bethlehem, PA.
The Quality Assurance Specialist will be responsible for
reviewing and ensuring all steps in the manufacturing, testing, storage and
distribution process for medical products at the Bethlehem Facility and are
performed in accordance with FDA’s applicable regulations and PDI’s standard
operating procedures. The Quality Assurance Specialist will handle the
quality oversight and auditing of production and incoming inspection
activities, review of change requests, and investigation of non-conformances
and out of specification reports. The Quality Assurance Specialist will have
the ability to work independently and to provide consultative advice within
specific areas of expertise.
Quality Assurance Specialist
- Reviews all steps performed and ensures
that the step in the manufacturing process has taken place as defined in
the Batch Production Record.
- Reports findings of in-process errors and
provides follow-up to ensure adequate completion of corrective actions.
- Performs and coordinates quality
investigations with appropriate levels of corrective/preventive actions
and closes in a timely manner.
- Supports product quality complaint
investigations, assisting in data processing of Adverse Events and
appropriate reporting for U.S. and Canada complaints. Supports the
receipt/review of product complaint samples. Participates in the
investigation and resolution of non-conformances of all types.
- Quality review of System Preventative
Maintenance activities.
- Support initiatives in Continuous Quality
Improvement.
- Provides training in GMP and quality
principles to personnel in all departments when assigned. Assists in
maintenance of training schedules and training records systems.
- Assists in the review and approval of
Change Controls.
- Assists in internal and supplier audits
and establishing/updating supplier and component specifications and
testing as needed.
- Assists with tracking and trending of
deviations and complaints.
- Follows all safety rules/regulations and
immediately reports infractions and/or workplace injuries/accidents to
proper personnel.
- Ensures for product disposition, e.g.,
approvals for release, distribution or rejection.
- Ensures labels are appropriately reviewed
and approved for use and meet all internal and external requirements
- Other duties as assigned
- Bachelor’s/Associates Degree in a
Science/ Engineering or related technical field
- Background in quality medical products
preferred
- Knowledge in the FDA’s regulations for
medical products 21 CFR part 210 and 211
- Strong communication skills &
organizational agility
- Solid organizational skills
- Strong knowledge of Microsoft Office
Applications and Lotus Notes database skillsets
- Basic of HTML and JavaScript computer
language preferred
- ISO 9001 or ISO 13485 and or regulatory
experience
All qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, national origin,
age, disability, protected veteran status, pregnancy, sexual orientation,
gender identity or expression, or any other reason prohibited by applicable
law.
Primary Location Pennsylvania-Bethlehem
Schedule Full-time
Job SHEQ
Unposting Date Ongoing
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