eQMS Specialist
This position will report to the Quality Management System (QMS) Manager. The eQMS (electronic Quality Management System) Specialist evaluates, tracks, trends, and monitors the electronic quality management system. 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.
Why Join Leiters Health?
Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further – Leiters Health is seeking talented individuals like you to join our dynamic team!
At Leiters Health, we're not just another pharmaceutical company – we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do.
- Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement.
- Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positivelyimpactpatients' lives.
- Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.
- Cutting-EdgeTechnology: Work withstate-of-the-artfacilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing.
- Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration.
Who We're Looking For:
We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today!
Essential Functions:
This description is intended to be illustrative of the major duties performed by the employee assigned to this position.
- 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.
Supervisory Responsibilities:
Experience and Necessary Competencies:
- 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.
- Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is a plus!
- Proficient written, verbal and oral English communication skills are required.
- Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel is required.
Physical Requirements:
- Ability to stand or sit for extended periods of time.
- Ability to lift, push and pull up to 50 pounds periodically.
Benefits:
- 100% employer paid medical plan.
- Dental & Vision insurance options including FSA & HSA
- 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
Timeline: We will be accepting applications on an ongoing basis until position is filled.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.
