Senior Quality Systems Application Analyst

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

As the Senior Quality Systems Application Analyst, you will play a critical role in enhancing the user experiences with cloud-based quality related applications and ensuring our integrated enterprise solution for the organization. Your responsibilities will include a variety of duties related to the integration, administration, upgrade, testing and support of Quality Systems enterprise software applications. Your ability to translate the requirements of our internal customers into robust solutions will be essential in this role.

The responsibilities:

• Provides technical project leadership in the planning, design, development, testing, and implementation of application software.
• Conducts software application testing and other preparation for software upgrades or new software implementation
• Monitors, analyzes, plans, and assists end-users with the implementation of new software releases and upgrades.
• Researches system enhancements and executes implementation.
• Conducts database analysis; researches and analyzes problems with applications and resolves or formulates solutions.
• Provides leadership in problem solving, which requires the consideration of the IT strategic plan and short term goals, the means by which to solve the problem, and development of associated action plans.
• Work with vendors to ensure system operability/functionality and to ensure success of system implementations and upgrades.
• Reviews projects, analyzes business requirements, recommends system changes, writes specifications and implements application changes to address changing application and end user requirements.
• Contributes to ongoing process to integrate end users requests with software functionality to address changing.
• Creates and maintains technical documentation and architecture diagrams as required.
• Analyzes and provides recommendations relating to application configuration and functionality of systems to ensure reliability for current and/or future use.
• Works directly with project managers to understand application objectives, develop scope of project, outline effort projections, determine schedules, and finalize plans.
• Establishes and enforces standards, policies and procedures for Quality/Lab Systems related application systems.
• Participate in the development and implementation of the information technology goals, objectives, policies, and priorities.
• Assist in assessing the strategic direction of information technology and in developing strategic plans for use of new technology.

Required Qualifications:

• Bachelor’s degree in Information Technology or Computer Science or equivalent experience in an Information Technology environment.
• Five years experience in Quality Systems discipline as an Information Technology Analyst or a related function performing
• User support
• Training
• Supporting installation, development, and maintenance of the business application software and servers, including the development of associated metadata and user interfaces
• PMP certification preferred
• Support large scale complex software application(s)
• Experience configuring Veeva application
• Experience in integrated SaaS enterprise solution network and infrastructure environment
• Demonstrates diagnostic skills and expertise to assist with problem determination and solution across the enterprise solution environment.
• Analyze software application problems and issues and drive to root cause solutions
• Create and meet deadlines
• Deal with multiple high priority issues simultaneously
• Develop and manage projects of significant scope with considerable impact on the organization
• Deal with controversial or sensitive issues
• Perform analysis at a high level
• Excellent written and oral communication skills

In return, you’ll be eligible for [1]:

• Day One Benefits
  • Spouse Life Insurance
  • Child Life Insurance
  • Paid Holidays
  • Paid Time Off
  • Paid Parental Leave and more
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

At Simtra, we recognize that attracting the best talent is key to our strategy and success as a company. As a result, we aim for flexibility in structuring competitive compensation offers to ensure we are able to attract the best candidates.​

The pay range reflected represents what we reasonably expect to pay for this job. The pay offered will depend on factors such as the candidate’s education, experience, skills, and geographical location. In addition to base pay, employees are eligible to participate in an annual bonus plan and employee ownership plan. Eligible employees also receive a comprehensive and highly competitive benefits package, including a variety of health, retirement, caregiving, emotional wellbeing, and other flexible benefits—plus elective options to support the diverse needs of our workforce.​

Salary Range: $120,000-$135,000

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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Originally posted on Himalayas