Quality Control Operations Specialist

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

The Operations Specialist, Quality Control position supports planning, execution, and governance for quality systems projects in the Quality Control (QC) department. This role requires an understanding of analytical workflow and instrumentation (HPLC, GC, KF, DSC, TGA, IR, MS, NMR, LC-MS, ICP-MS and other tests) to critically evaluate, coordinate, and implement changes and process improvements. The specialist demonstrates the ability to work independently with minimal guidance, supports audit readiness, responds to audit findings, manages project timing and costs, and maintains a clean and safe work environment.

• Drive continuous improvement through leading cross‑functional teams to implement system improvements, respond to new regulations, address evolving business needs, and enhance training for QC functional areas.
• Manage the full lifecycle of deviations, investigations, CAPA's, audit responses, and change controls within QC, ensuring timely closure, robust root cause analysis, and effective preventive actions.
• Assist in identifying, maintaining, and reporting functional KPIs to site management to enable data‑driven decision making and performance tracking.
• Participate in data integrity initiatives and related processes within QC functional areas.
• Work cross‑functionally to support and expand digitization operations within QC (e.g., STARe, Ommnis, Diffracto suite, Chromeleon, LIMS, and other software systems).
• Assist in drafting and reviewing QC‑related SOPs, technical reports, user requirements, and other documentation using the principles of ALCOA+.
• Represent QC interdepartmentally on QC projects, facilitating efficient and collaborative interactions with internal and external stakeholders.
• Other duties as assigned.
• Adhere to the GMP requirements defined within 21 CFR parts 210 & 211, 820, ICH Q7, and safety standards set under ISO 14001 & 45001.

• Bachelor’s Degree in Chemistry, Biology, or another Life Science discipline.
• 5+ years in a cGMP analytical laboratory environment.

• Master’s Degree in Chemistry, Biology, or another Life Science discipline.
• Experience working cross‑functionally and developing strong business partner relationships.
• Experience working with teams across multiple shift schedules that cover 24 hours/7 days.
• Ability to manage multiple projects simultaneously with minimal supervision.
• Proficient with Microsoft Office products (Outlook, Word, Excel, PowerPoint).

Pay Range: $63,600 – $95,500. The offer range represents the anticipated low and high end of the base pay compensation for this position. Actual compensation will be determined by factors such as location, level of experience, education, skills, and other job‑related factors. Position may be eligible for sales or performance‑based bonuses.

Benefits offered by the company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.