Quality Control Operations Specialist

About the role

The Operations Specialist, Quality Control position supports planning, execution, and governance for quality systems projects in the Quality Control (QC) department. This position will have an understanding of the analytical workflow and instrumentation in a QC lab to be able to critically evaluate, coordinate, and implement changes and process improvements.

Responsibilities

• Demonstrate the ability to work on, and solve problems independently with minimal guidance.
• Participate in duties and actions that support the QC functional areas to maintain an audit ready state and participate in responses to audit findings.
• Maintain project timing/costs and interact with internal/external clients to assure project goals are met.
• Maintain a clean and safe working environment.
• Draft and review departmental documents.
• Participate in data integrity initiatives.
• 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.
• Afford QC functional KPIs to site management, enabling data-driven decision making and performance tracking.
• Represent QC interdepartmentally on QC projects, facilitating efficient and collaborative interactions with internal and external stakeholders.
• Adhere to GMP requirements defined within 21 CFR parts 210 &211, 820, ICH Q7, Safety standards set under ISO 14001 & 45001.

Qualifications

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

Skills

• Proficient with Microsoft Office Product (Outlook, Word, Excel, and PowerPoint).

Benefits

• Health insurance
• Paid time off (PTO)
• Retail contributions
• Other perquisites

Pay

$63,600-$95,500. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered 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.