1 Senior Analyst, Quality Management Systems (QMS) Job in Danbury, CT
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Senior Analyst, Quality Management Systems (QMS)
$98k-121k (estimate)
Full Time | Wholesale
2 Months Ago
Mannkind is Hiring a Senior Analyst, Quality Management Systems (QMS) Near Danbury, CT
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:
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, 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
- SME for the EDMS, providing support to users and supporting continuous process improvements.
- 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
Job Summary
JOB TYPE
Full Time
INDUSTRY
Wholesale
SALARY
$98k-121k (estimate)
POST DATE
05/03/2024
EXPIRATION DATE
07/29/2024
WEBSITE
mannkindcorp.com
HEADQUARTERS
DOYLESTOWN, PA
SIZE
200 - 500
FOUNDED
1991
TYPE
Public
CEO
MICHAEL CASTAGNA
REVENUE
$50M - $200M
INDUSTRY
Wholesale
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About Mannkind
Mannkind researches, develops and commercializes therapeutic products for the treatment of diabetes and pulmonary arterial hypertension.
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