Sr. Quality Associate II / Principal, QA -Computer Systems

Summary

We are seeking an experienced Quality Assurance professional to join the General Computer Systems Group, supporting key initiatives such as the Laboratory Execution System (LES) project and SAP Quality Master Data management. This role is offered at three levels—Sr. Quality Associate I, Sr. Quality Associate II, and Principal Quality Associate—depending on experience and qualifications.

Key Responsibilities

• Sr. Quality Associate I:
  • Partner with management to develop and implement solutions to meet quality objectives.
    • Use subject‑matter expertise to make independent decisions within defined areas.
    • Participate on cross‑functional project teams.
    • Collect, analyze, and interpret data.
    • Demonstrate sound decision‑making with moderate guidance.
    • Uphold cGMP and safety practices; model company values and integrity.
    • Perform additional duties as assigned.
• Sr. Quality Associate II:
  • Advise and influence technical decisions within business units.
    • Collaborate with management and, when necessary, regulatory officials.
    • Lead cross‑functional teams and communicate proposals to senior management through successful project completion.
    • Mentor team members as needed.
    • Prepare, review, and/or approve SOPs, change controls, incident entries, and investigation reports.
    • Make strong, independent quality decisions with minimal guidance.
    • Perform additional duties as assigned.
• Principal Quality Associate:
  • Act as a technical authority influencing quality and business direction.
    • Lead high‑impact, multi‑disciplinary project teams from proposal to completion.
    • Maintain and advance essential technologies.
    • Interact regularly with management and regulatory officials.
    • Prepare, review, and/or approve SOPs, change controls, investigations, and regulatory documents.
    • Easily prioritize and adapt to changing business needs.
    • Provide SAP validation review and approval.
    • Make fully independent quality decisions and influence stakeholders across departments.
    • Perform additional duties as assigned.

Position‑specific Responsibilities

• May Include:
  • Acting as author, reviewer, approver, administrator, or coordinator for quality systems.
  • Supporting SAP QM (inspection lots, quarantine, batch release, production order issues).
  • Providing SAP inspection plan support for Annual Product Reviews.
  • Supplying Quality input for validations, clinical studies, stability programs, and regulatory submissions.
  • Representing the Quality Manager in meetings and project forums.
  • Communicating effectively across all levels of the organization.

Requirements

• Sr. Quality Associate I:
  • BS/BA, preferably in a STEM field.
    • Minimum 5 years relevant experience or equivalent education/experience/competency mix.
• Sr. Quality Associate II:
  • BS/BA, preferably in a STEM field.
    • Minimum 6 years relevant experience or equivalent education/experience/competency mix.
• Principal Quality Associate:
  • BS/BA, preferably in a STEM field (required).
    • Minimum 8 years relevant experience or equivalent education/experience/competency mix.

Work Environment

• Office and a laboratory/manufacturing environment or warehouse.
  • Exposure to biological fluids with potential exposure to infectious organisms.
  • Exposure to occasional extreme cold below 32* in production areas.
  • Exposure to electrical office and laboratory equipment.
  • Personal protective equipment is required such as protective eyewear, garments and gloves.
  • Sitting or standing for 2-4 hours per day.

Qualifications

• Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences.
• Perform tasks by following a set of written or oral instructions/procedures.

Equal Employment Opportunity

We provide equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.