Careers - MannKind Corporation

        
                            Position: 
                            
	                            	QA Specialist, (QMS)
	                           	
                                            Location: 
                                        
                                                Danbury, CT

                            Job Id: 
                            
                                    11084
                            
                            # of Openings: 
                            
                                1
                            
At MannKind our employees are our number one asset, and we continue becoming a tight-knit community where each of us plays a critical role in our collective success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.

Position Summary:

Performs a wide variety of activities in Quality Assurance (QA) to ensure compliance with regulatory and company requirements by reviewing documentation and supporting QA systems in accordance with GxP, FDA, ISO and regulatory requirements.

Essential duties and key job responsibilities and essential functions:
Review and approve change requests, SOPs (Standard Operating Procedures), and documents for compliance and adherence to company requirements
Work with change control and document authors to ensure documents are clear, comprehensive and align with other documents in the quality system. Assess processes and recommend process/system improvements. Independently resolve issues related to compliance and document quality whenever possible.  
Ability to identify Site Significant Changes and assess the impact of change requests, liaison to Change Management Review Board.
Support notification and approval for Partner changes
Responsible for maintaining the data archive
Subject matter expert (SME) for the EDMS, providing support to users and supporting continuous process improvements.
Subject matter expert (SME) for TrackWise Digital
Identify potential process improvements, and assist in implementation of improvements
Provide guidance on compliance issues identified and questions raised by colleagues (inter-departmental and intra-departmental)
Supports maintaining the data archive
Maintain tracking logs and files as needed
Support and/or participate in audits/inspections
Responsible for observing all Company, Health, Safety and Environmental guidelines
 
Minimum qualifications to perform the job; specific skills, education, knowledge and job experience necessary to perform essential duties; physical requirements for job if any.
BS/BA degree in a scientific or technical discipline with 4-6 years related experience or MS with 2-4 years of experience, preferably pharmaceutical industry or an equivalent combination of experience and training
Experience in reviewing/writing Change Controls, and document review for regulatory compliance is preferred
Experience in a GxP environment
Strong communication and interpersonal skills
Detail orientated 
Good technical writing skills

                            Pay Range: $68,000 - $102,000 per year
                        
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