Simtra BioPharma Solutions

Simtra BioPharma Solutions

Senior Quality Systems Application Analyst (Remote)

Remote - US · Senior

Sponsorship not specified$120k-$135kDetected 12 days ago
GMPLeadershipCommunicationProblem Solving

About the role

  • 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.
  • 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.

Responsibilities

  • Provides technical project leadership in the planning, design, development, testing, and implementation of application software.
  • Works directly with project managers to understand application objectives, develop scope of project, outline effort projections, determine schedules, and finalize plans.
  • Reviews projects, analyzes business requirements, recommends system changes, writes specifications and implements application changes to address changing application and end user requirements.
  • Assist in assessing the strategic direction of information technology and in developing strategic plans for use of new technology.
  • This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.
  • Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Requirements

  • 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
  • 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.

Nice to have

  • PMP certification preferred

Compensation

  • $120,000-$135,000

Benefits

  • 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.
  • Day One Benefits
  • Spouse Life Insurance
  • Child Life Insurance
  • Paid Parental Leave and more
  • Medical & Dental Coverage
  • Flexible Spending Accounts

Company info

  • 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.
  • While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.

Equal 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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This listing is sourced directly from Simtra BioPharma Solutions's careers page and normalized into a canonical job model.