Quality Control Lead (Chemistry) - 3rd Shift

Augustbio; Nashville (TN); On-site; USD 75,000 - 110,000; Full time

Job summary

August Bioservices is seeking a Quality Control Lead to oversee chemical analyses in a fast-growing environment. The role requires extensive experience in pharmaceutical testing and analytical procedures, contributing to high-quality standards and regulatory compliance. Join a team that values innovation and integrity in improving global health!

Qualifications

• 7+ years pharmaceutical experience or 3+ years with Master's degree.
• Expertise in USP/EP testing and chromatographic techniques.
• Experience in leading training and performing method validations.

Responsibilities

• Perform chemical analyses on raw materials and finished products.
• Support training of laboratory chemists and document activities.
• Conduct maintenance and troubleshooting of analytical equipment.

Skills

Analytical Procedures

Wet Chemical Testing

Instrumentation

Root Cause Analysis

Regulatory Compliance

Education

Bachelor’s degree in chemistry, biology, or related science

Master’s degree in related field

Tools

LC Equipment

GC Equipment

Microsoft Office

Job description

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner, we provide a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes. We play a vital role in the global pharmaceutical industry by helping develop molecules that can become life-changing therapies of tomorrow. To support our growth, August is investing in a two-phase expansion including a new state-of-the-art facility adjacent to our current location. We offer dynamic opportunities, rewarding career paths, and the chance to make a difference in global health. Join us and grow with August!

Position Overview: The Quality Control Lead operates independently to perform chemical analyses of raw materials and finished products under cGMP guidelines. The Lead supports laboratory chemists through training, expertise in USP/EP monograph testing, and instrumentation understanding. Responsibilities include authoring test methods, specifications, certificates of analysis, leading investigations, and training personnel. The Lead also performs method verifications and transfers, and serves as a resource for laboratory operations, equipment qualification, chromatography best practices, and quantitative analysis.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Serve as a subject matter expert in analytical procedures, including wet chemical analyses and instrument-based methods.
• Foster communication and training of chemists at all levels.
• Maintain a safe, clean, and organized work environment.
• Support lab waste management, reagent labeling, and storage.
• Perform testing on raw materials, finished products, in-process, and stability samples.
• Prepare test solutions, compounds, or reagents for analysis.
• Perform assays, impurity/degradant, and solvent determinations using chromatographic techniques such as TLC, GC, HPLC, MS, and UPLC.
• Conduct maintenance and troubleshooting on analytical equipment.
• Collaborate with cross-functional teams on projects, transfers, and investigations.
• Perform daily calibrations and preventative maintenance.
• Document all activities clearly and concisely per cGMP standards.
• Create and execute method protocols and reports.

QUALIFICATIONS:

• Bachelor’s degree in chemistry, biology, or related science with 7+ years of pharmaceutical experience, or a master’s degree with 3+ years of experience.

KNOWLEDGE, SKILLS, & ABILITIES:

• Perform testing on various samples and serve as a subject matter expert in pharmaceutical manufacturing.
• Train analysts on wet chemical testing and instrumentation.
• Complete complex investigations with root cause analysis and CAPAs.
• Document activities in a concise manner per cGMP.
• Expertise in LC and GC equipment and USP/EP monograph testing.
• Lead training related to OOS/CAPAs.
• Support sample submissions and testing.
• Maintain current training in the Quality Management System.
• Operate safely, adhering to PPE and hazardous substances policies.
• Proficient in Microsoft Office and LC software systems.
• Utilize root cause analysis techniques and present KPIs or project updates to leadership.
• Act as management representative for GMP compliance in the lab.

Our Credo emphasizes care, discovery, excellence, and responsibility. We aim to unlock potential at every level and are committed to regulatory compliance and environmental stewardship. If this environment resonates with you, we want you on our team!

August Bioservices is an equal opportunity employer. We value diversity and base employment decisions on merit, competence, and business needs, without discrimination based on protected statuses.