QA Specialist - On the Floor Support (3rd Shift & Weekend Shift)

August Bioservices, LLC; Nashville (TN); On-site; USD 60,000 - 80,000; Full time

Job summary

August Bioservices, LLC is looking for a proactive QA Specialist in Nashville, TN to provide real-time quality oversight across manufacturing and packaging operations. The role focuses on ensuring cGMP compliance and fostering a quality culture. The ideal candidate has a Bachelor’s degree in a scientific discipline and 2–5 years of experience in a GMP-regulated environment. Join us to make a significant impact in global health and help develop therapies for tomorrow's challenges.

Qualifications

• 2–5 years in a GMP-regulated environment, with QA support experience.
• Knowledge of FDA/ICH regulations and QA documentation practices.
• Ability to work flexible shifts, including evenings or weekends.

Responsibilities

• Provide real-time QA support on the production floor.
• Ensure adherence to batch records and validated procedures.
• Act as a Designated Observer for controlled substance handling.
• Collaborate with teams to support operational flow.

Skills

Attention to detail

Hands-on guidance

Strong problem-solving skills

Communication

Interpersonal skills

Education

Bachelor’s degree in a scientific discipline

Tools

Master Control

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 that provides 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. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state‑of‑the‑art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!

We are seeking a proactive QA Specialist to provide real-time quality oversight across manufacturing, packaging, inspection, and warehouse operations. The role ensures cGMP compliance, supports production activities, and promotes a strong quality culture. The ideal candidate is detail‑oriented, hands‑on, and able to provide guidance to operators while maintaining inspection readiness.

Responsibilities

• Maintain a daily presence on the production floor to provide real‑time QA support and guidance
• Ensure adherence to batch records, SOPs, and validated procedures during manufacturing, packaging, and inspection activities
• Perform QA line clearances, in‑process checks, and AQL inspections, and support visual inspection and automated inspection processes
• Act as a Designated Observer for controlled substance handling, ensuring compliance with internal and regulatory requirements
• Routinely walk through production, lab, and warehouse areas to assess GMP compliance and escalate issues as needed
• Verify labeling issuance, reconciliation, and documentation to ensure proper handling of materials and finished products
• Provide on‑floor coaching and guidance to operators, reinforcing GMP compliance and best practices
• Collaborate with Manufacturing and Planning teams to prioritize lot disposition, minimize downtime, and support operational flow
• Monitor cleaning, sanitization, and environmental controls prior to critical operations
• Promote a quality‑focused culture by sharing lessons learned and encouraging proactive issue identification
• Maintain knowledge of deviation, OOS/OOT, and CAPA processes to support investigations if required
• Assist in gathering facts, reviewing documentation, and providing QA input when deviations occur on the floor
• Understand root cause analysis tools (5 Whys, Fishbone, FMEA) to support quality discussions
• Review, revise, and proofread GMP documentation, including batch records, SOPs, and logbooks
• Support document control processes and ensure training documentation is correctly linked to controlled systems
• Ensure compliance with regulatory standards (FDA, ICH, DEA) and Good Documentation Practices
• Conduct routine walk‑throughs to maintain inspection readiness
• Support internal audits and regulatory inspections by providing floor‑level guidance and documentation as needed

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent experience
• 2–5 years in a GMP‑regulated environment, with experience in on‑the‑floor QA support
• Knowledge of cGMPs, FDA/ICH regulations, and QA documentation practices
• Familiarity with Master Control or electronic quality systems preferred
• Strong communication, problem‑solving, and interpersonal skills
• Ability to work flexible shifts, including evenings or weekends as required

Preferred Qualifications

• Experience with automated visual inspection processes
• Knowledge of controlled substance handling
• Prior involvement in regulatory inspections

Work Environment & Physical Demands

• Regular presence in GMP manufacturing and cleanroom environments with proper gowning
• Occasional off‑shift, weekend, or extended coverage may be necessary

August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.