eQMS Specialist

Leiters Inc•Englewood, CO

About The Position

The eQMS (electronic Quality Management System) Specialist evaluates, tracks, trends, and monitors the electronic quality management system and will report the the QMS Manager. The position is responsible for maintaining and improving the eQMS to comply with FDA and industry standards. The position will support QMS functions within the functionality of the eQMS. The candidate should have an excellent understanding of cGMP requirements as well as Quality System functions and technology platform capabilities. This role serves as the liaison between the eQMS vendor and Leiters Health. The eQMS Specialist will also provide audit support as it relates to document control activities.

Requirements

Bachelor’s degree in software engineering, IT or other relevant field and/or equivalent experience.
3+ years of relevant software management experience.
Experience with eQMS platforms is required. Salesforce / Dot Compliance platforms preferred.
Excellent organizational skills with a strong attention to detail and results oriented mindset.
Works well under pressure and can prioritize workloads.
Works well in a team environment as well as individually.
Able to identify potential adverse issues.
Proficient written, verbal and oral English communication skills are required.
Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel is required.

Nice To Haves

Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is a plus!

Responsibilities

Have a working knowledge of the Salesforce platform and DotCompliance system.
Be experienced in system implementation and roll out.
Have experience with system validation requirements as specified in GAMP 5
Ensure ongoing maintenance of the eQMS system including all documentation.
Support external and internal audits with respect to eQMS functionality and compliance.
Prepare reports within the eQMS to track and trend activities within the system.
Gather information from multiple departments for trending and presentation to management.
Identify trends in the industry and recommend improvements.
Work with a team to ensure that the systems involved in an outsourcing facility are in a state of control.
Assist with managing the document control system to ensure the integrity and accessibility of documents.
Assist with implementing corrective actions related to document control findings from audits.
Document and validate workflows within the eQMS system
Responsible for working directly with the eQMS vendor to assess and document impact of system updates to the Leiters QMS.
Write deviations as necessary.
Assist with training staff on document control processes and systems.
Other duties as assigned.

Benefits

Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
Flexible Spending & Health Savings Accounts (FSA & HSA) available
Dental & Vision insurance
Employer Paid Life Insurance & Employee Assistance Program
Short Term & Long-Term Disability Insurance
Up to 4% 401K Matching (100% vested on day one!)
Generous Paid Time Off Options – vacation,sick, paid leave and holidays!
$5,250 Annual Tuition Reimbursement after 6 months
$1,000 Referral Bonus Program with no limit
Eligible for annual bonus program