Quality Assurance Specialist
Job Description:
Location:
This is an onsite position.
Some work could be performed remotely, but need local candidates who are open to working onsite.
A' The Quality Specialist will perform selected quality assurance activities during the execution of a Document Management improvement project.
A' The Quality Specialist must:
A cents EUR cents Have basic knowledge of industry regulations and standards A cents EUR cents Use basic analytical skills to develop solutions to task-related problems A cents EUR cents Provide support for moderate/complex problems by assisting in fact-finding, data gathering and verification A cents EUR cents Work under general supervision following standard procedures; few instructions needed on a routine basis A' Activities to be performed include the following:
A cents EUR cents Reads, understands, and follows SOP's and complies with cGMP's A cents EUR cents Writes new standard operating procedures or revises existing documentation utilizing document management systems.
A cents EUR cents Supports the evaluation and disposition of labelling, raw materials, intermediates and finished products through timely evaluation of batch records, laboratory results and other cGMP documents.
A cents EUR cents Supports the issuance and reconciliation of GMP documentation A cents EUR cents Electronic system usage with tools such as Trackwise, SAP, AZDoc and FileTrail.
A cents EUR cents Maintains the document archival room(s) in orderly manner.
A cents EUR cents Filing and maintenance of all controlled documents and records.
A cents EUR cents Maintain accurate and timely document and record databases and logs.
A cents EUR cents Issues production records, logbooks and notebooks for GMP use.
A cents EUR cents Scans, verifies and archives documentation and records.
A cents EUR cents Prepare records for off-site storage / archive retrieve, return.
A' Essential
Qualifications:
A cents EUR cents HS diploma or AA degree in relevant area A cents EUR cents 0-3
years experience in biopharmaceutical/pharmaceutical industry.
A cents EUR cents Computer literate (Microsoft Word, Excel, PowerPoint, Visio) A' Job Requirements:
Job Description:
Location:
This is an onsite position.
Some work could be performed remotely, but need local candidates who are open to working onsite.
A' The Quality Specialist will perform selected quality assurance activities during the execution of a Document Management improvement project.
A' The Quality Specialist must:
A cents EUR cents Have basic knowledge of industry regulations and standards A cents EUR cents Use basic analytical skills to develop solutions to task-related problems A cents EUR cents Provide support for moderate/complex problems by assisting in fact-finding, data gathering and verification A cents EUR cents Work under general supervision following standard procedures; few instructions needed on a routine basis A' Activities to be performed include the following:
A cents EUR cents Reads, understands, and follows SOP's and complies with cGMP's A cents EUR cents Writes new standard operating procedures or revises existing documentation utilizing document management systems.
A cents EUR cents Supports the evaluation and disposition of labelling, raw materials, intermediates and finished products through timely evaluation of batch records, laboratory results and other cGMP documents.
A cents EUR cents Supports the issuance and reconciliation of GMP documentation A cents EUR cents Electronic system usage with tools such as Trackwise, SAP, AZDoc and FileTrail.
A cents EUR cents Maintains the document archival room(s) in orderly manner.
A cents EUR cents Filing and maintenance of all controlled documents and records.
A cents EUR cents Maintain accurate and timely document and record databases and logs.
A cents EUR cents Issues production records, logbooks and notebooks for GMP use.
A cents EUR cents Scans, verifies and archives documentation and records.
A cents EUR cents Prepare records for off-site storage / archive retrieve, return.
A' Essential
Qualifications:
A cents EUR cents HS diploma or AA degree in relevant area A cents EUR cents 0-3
years experience in biopharmaceutical/pharmaceutical industry.
A cents EUR cents Computer literate (Microsoft Word, Excel, PowerPoint, Visio) A'.
Estimated Salary: $20 to $28 per hour based on qualifications.
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