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Associate, Quality Control
Job Description
Our client is seeking a highly motivated and detail-oriented Associate in Quality Control (QC) Chemistry to support the startup and operational readiness of the QC laboratory. This role involves collaborating with cross-functional teams to ensure the seamless implementation of laboratory systems, performing critical validation activities, and maintaining GMP compliance. The successful candidate will play a key role in method transfers, equipment qualification, and laboratory operations, contributing to the delivery of high-quality products. This opportunity offers career growth within a dynamic environment, exposure to state-of-the-art analytical techniques, and the chance to support impactful projects in the biopharmaceutical industry.
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 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.
Qualifications:
- 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.
- 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 validation, verification, and transfer.
- Excellent interpersonal skills with the ability to collaborate across teams and adapt to varying communication styles.
Work Location: Onsite - Holly Springs, North Carolina
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Ready to take the next step in your career? Explore job opportunities in the bustling area around Holly Springs, North Carolina, where growth awaits at every corner. Nestled in the heart of the Tar Heel State, Holly Springs offers a perfect blend of small-town charm and big-city amenities. From its vibrant arts scene at the Holly Springs Cultural Center to the mouthwatering Southern cuisine found at local favorites like the Mason Jar Tavern, this region has something for everyone. Boasting proximity to Raleigh, Durham, and Chapel Hill, as well as being a stone's throw away from attractions like the NC Museum of Art and PNC Arena, Holly Springs provides a unique and attractive environment for professionals looking to thrive. Dive into our job listings today and discover the endless opportunities this lively area has in store for you!