Associate Quality Control

Title:

Associate Quality Control

Duration:12 Months

Location:
Holly Springs, NC

Fully Onsite
- Standard hours
- Up to 5 days per month may require shift flexibility.

Ideal Candidate: B.S. and 3+YOE would be ideal in a chemistry lab environment.

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

• Bachelor's degree or higher in chemistry or a related scientific discipline.
• One to six years of relevant laboratory experience in a GMP-regulated pharmaceutical or biopharmaceutical manufacturing environment, with a strong background in analytical testing.

• Demonstrate an understanding of industry regulations, 5S, data integrity, compliance standards, ALCOA+ principles with attention to details in a GMP environment.
• Execute analytical testing and method transfer activities using instruments and platforms such as TOC, conductivity, osmolality, the HACH TL2350 turbidimeter, UV spectroscopy, pH meters and support testing using HPLC/UPLC.
• Perform testing in accordance with applicable pharmacopeias, including USP, EP, JP, and others.
• Provide daily support for compendial testing, solution preparation, and other related scientific activities.
• Collaborate cross-functionally with site teams to support preventive maintenance activities for laboratory equipment.
• Draft, revise, and review technical and quality documentation, including SOPs, test methods, and documents within the CDOCS system.
• Assist with procuring laboratory consumables and critical reagents required for startup activities using the CIMS system.
• Actively participate in audits, quality initiatives, and cross-functional projects with site or global impact.
• Responsible to follow and use laboratory systems procedures such as LIMS, LMES and CIMS.
• Demonstrate excellent interpersonal skills, with the ability to collaborate across teams and adapt to various communication styles.
• Provide routine operational support on weekends and holidays, as required.

• Proficiency in analytical laboratory techniques, instrumentation, and troubleshooting.
• Strong technical writing, documentation, and communication skills.
• Experience using laboratory systems such as LIMS, LMES and CIMS.
• Strong knowledge of relevant pharmacopeias.

High school/GED + 2 years work experience or Associates degree and 6 months work experience or Bachelors degree

• Must have a chemistry background
• GMP experience
• Empower experience

• Laboratory testing of manufactured materials.
• Training on new methods
• Audit readiness
• Support startup

Yes

• No chemistry background
• Not able to be flexible.
• Not able to work overtime when needed.