Senior Analyst, Quality Management Systems (QMS) - Job at Mannkind Corporation in Danbury, CT

Senior Analyst, Quality Management Systems (QMS)

Danbury, CT

Posted 15 days ago

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Job Description

Position: Senior Analyst, Quality Management Systems (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

Apply for this Position

Mannkind Corporation is proud to be an Equal Employment Opportunity employer. We provide equal employment opportunity (EEO) to all persons regardless of race, creed, color, religion, national origin, ancestry, gender (including pregnancy, breastfeeding or medical condition related to pregnancy or breastfeeding), age, physical or intellectual disability, sexual orientation, gender identity, gender expression, gender stereotyping, marital status, military or veteran status, citizenship, genetic characteristic or information, or any other characteristic protected by applicable federal, state, or local law.

Job Summary

Company

Mannkind Corporation

Start Date

As soon as possible

Employment Term and Type

Regular, Full Time

Required Education

Bachelor's Degree

Required Experience

4 to 6 years