Specialist, Sterility Assurance Quality Assurance Shop Floor

Specialist, Sterility Assurance Quality Assurance Shop Floor

Location: Summit West, S-12

Duration: 6 Months

Work Schedule: Wed - Sat 7:00 AM - 5:30 PM

The Specialist is responsible for quality activities for the QA shop floor in accordance with internal policies, standards, procedures and Global cGMP. This position is part of the sterility assurance team with a focus on contamination control strategies.

Functional responsibilities include ensuring manufacturing compliance with applicable procedures and working with operations to resolve manufacturing issues.

• Advanced knowledge and experience with cGMP manufacturing, Quality, and Compliance.
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
• Action-oriented, customer-focused, skilled in decision‑making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Independent mindset.
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
• Work is self‑directed.
• Confident in making decisions for non‑routine issues.
• Routinely recognizes and resolves quality issues; informs management of proposed solutions and seeks guidance on complex issues.
• Develops procedures.
• Proposes solutions for complex issues and works with management to resolve.
• Follows established procedures and performs work as assigned.
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
• Understands continuous improvement and improves efficiency and productivity within the group or project.
• Builds relationships internally within and with cross‑functional teams.
• Contributes to goals within the work group.
• Recognizes conflict and notifies management with proposed recommendations for resolution.
• Understands environmental monitoring, disinfection principles, and aseptic/cleanroom environments.
• Able to prepare written communications and convey problems to management with clarity and accuracy.
• Effective multi‑tasking.
• Knowledge of US and global cGMP requirements.
• Excellent verbal and written communication skills.

• High School Degree required.
• Relevant college or university degree preferred.
• Minimum 5 years relevant work experience.
• Equivalent combination of education and experience acceptable.

• Perform QA shop floor oversight ensuring proper aseptic techniques.
• Strong authorship and ability to critically review investigations, interpret results, and generate technical conclusions consistent with quality risk‑management principles.
• Skilled in planning and organizing, decision‑making, and building relationships.
• Knowledge of quality processes, including change control, deviations, investigations, and CAPA management.
• Effective multi‑tasking.
• Required availability for weekend and off‑shift hours.

Work is performed in a typical office and manufacturing suite environment. While in the office, work is generally performed seated, but may require standing and walking when on the floor. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.