Job Title: Associate Quality Control
Location: Holly Springs NC – 100% Onsite
Duration: 12 Months with possible extension
Terms: Contract W2
Description:
Fully Onsite - Standard hours - Up to 5 days per month may require shift flexibility.
Ideal Candidate: B.S. and 1-3 YOE would be ideal in a chemistry lab environment.
Position Summary:
We are seeking a highly motivated and experienced Senior Associate in Quality Control (QC) Chemistry to support the startup and operational readiness of our QC 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.
Key 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 HPLC, UPLC, TOC, 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.
Preferred Qualifications:
• Bachelor's degree or higher in Chemistry, Biochemistry, Chemical Engineering, Physics, 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.
• Familiarity with laboratory systems such as LIMS and LMES/CIMS.
• Demonstrated understanding of industry regulations, data integrity, and compliance standards.
• Strong technical writing, documentation, and communication skills.
• Experience with method and equipment validation, including verification, transfer, and change control.
• Excellent interpersonal skills with the ability to collaborate across teams and adapt to varying communication styles.
Top 3 Skills:
Must be flexible
Must have a chemistry background
Nice to have: cGMP knowledge
Day to Day Responsibilities:
Daily responsibilities include routine sample testing, method transfers, and method validations based on laboratory activities.
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