Associate Quality Control

Contract position based out of Holly Springs, NC.

About the role

We are seeking a highly motivated and experienced Associate in Quality Control Chemistry to support the startup and operational readiness of our QC laboratory. This individual will work with minimal supervision to lead and contribute to critical activities, including system qualifications, method transfers, and laboratory operations in a GMP-regulated environment.

Responsibilities

• Collaborate cross-functionally with site teams to implement work order and preventative maintenance systems for laboratory equipment.
• Review and contribute to validation documentation to support onboarding of equipment and computerized systems.
• Draft, revise, and review technical and quality documentation, such as SOPs, test methods, technical assessments, validation reports, trend reports, and safety evaluations.
• Assist in the procurement of laboratory consumables and critical reagents required for startup activities.
• Coordinate and execute training and method transfer activities for instruments including H/UPLC, TOC, Conductivity, Osmolality, and other chemistry-based platforms.
• Actively participate in audits, quality initiatives, and cross-functional projects with site or global impact.
• Provide routine operational support during weekends and public holidays as required.

Requirements

• Bachelor's degree or higher in Chemistry, Compendial testing, or a related scientific discipline.
• Minimum of 4 years of relevant laboratory experience in a GMP pharmaceutical or biopharmaceutical manufacturing environment with a strong background in analytical testing.
• Proficient in analytical laboratory techniques and instrumentation.
• Demonstrated understanding of industry regulations, data integrity, and compliance standards.
• Strong technical writing, documentation, and communication skills.
• Experience with method validation, verification, and transfer.

Qualifications

• Familiarity with laboratory systems such as LIMS and LMES/CIMS.
• Hands-on Empower experience.
• Excellent interpersonal skills with the ability to collaborate across teams and adapt to varying communication styles.
• High school/GED + 2 years of work experience, or Associate's degree and 6 months of work experience, or Bachelor's degree.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan
• Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Pay

The pay range for this position is $28.00 - $30.00/hr. Individual