QC Chemistry Lead

Accentuate Staffing; Raleigh (NC); Presencial; USD 70 000 - 100 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive pay

Benefits package

Resumo da oferta

A leading pharmaceutical firm is seeking a QC Chemistry Lead in Raleigh, NC. You will lead a team of QC chemists, ensuring compliance with regulations and supporting product release. The ideal candidate has over 5 years of pharmaceutical QC experience, strong analytical skills, and leadership experience. Monitoring instruments like HPLC and GC will be part of your role. This position offers competitive pay and benefits, working onsite in a fast-paced environment.

Qualificações

• 5+ years of pharmaceutical QC laboratory experience.
• 1–3 years of leadership or senior-level experience.
• Experience with OOS and CAPA investigations.

Responsabilidades

• Lead and mentor a team of QC chemists.
• Oversee analytical testing and ensure compliance.
• Investigate deviations and ensure sound conclusions.

Conhecimentos

Analytical chemistry

Leadership

cGMP regulations

Problem-solving

Communication

Formação académica

Bachelor’s or Master’s degree in Chemistry or related field

Ferramentas

HPLC

GC

FTIR

UV-Vis

LIMS

Descrição da oferta de emprego

Accentuate Staffing is partnering with a leading pharmaceutical company who is hiring for a QC Chemistry Lead. This is a direct hire opportunity, offering competitive pay and benefits, working onsite. The ideal candidate has strong analytical chemistry experience, leadership within a QC lab, and a deep understanding of cGMP-regulated environments.

Responsibilities

1. Lead, mentor, and support a team of QC chemists, ensuring compliance with laboratory procedures and regulatory standards
2. Oversee analytical testing of raw materials, in-process samples, finished products, and stability samples
3. Investigate deviations and OOS results, implementing CAPAs and ensuring scientifically sound conclusions
4. Maintain and troubleshoot analytical instrumentation including HPLC, GC, FTIR, and UV-Vis
5. Ensure data integrity and proper documentation in accordance with GLP, cGMP, and regulatory requirements
6. Collaborate cross‑functionally with QA, Manufacturing, and Regulatory teams to support product release
7. Participate in method validation, transfer, and verification activities
8. Support audits and regulatory inspections, ensuring lab readiness at all times
9. Train and develop laboratory staff on analytical techniques and compliance standards
10. Drive continuous improvement initiatives within the QC laboratory

Requirements

1. Bachelor’s or Master’s degree in Chemistry, Biochemistry, or related scientific field
2. 5+ years of pharmaceutical QC laboratory experience with strong analytical chemistry background
3. 1–3 years of leadership or senior‑level experience within a QC lab
4. Hands‑on experience with HPLC, GC, UV‑Vis, FTIR, titrations, and wet chemistry techniques
5. Strong knowledge of cGMP, GLP, FDA, ICH, and USP guidelines
6. Experience with LIMS and chromatography data systems (e.g., Empower)
7. Proven experience with OOS, deviations, and CAPA investigations
8. Experience supporting audits and regulatory inspections
9. Strong leadership, communication, and problem‑solving skills
10. Ability to work in a fast‑paced, regulated manufacturing environment