August Bioservices

US-based CDMO for end-to-end drug development

QA Specialist - On the Floor Support

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeNashville, TN, USANo salary listedIn-person

About the Job

Requirements

A bachelor's degree in a scientific discipline, or equivalent experience.
Two to five years of experience in a good manufacturing practice-regulated environment, including on-the-floor quality assurance support.
Knowledge of current good manufacturing practices, Food and Drug Administration and International Council for Harmonisation regulations, and quality assurance documentation practices.
Regular presence in good manufacturing practice manufacturing and cleanroom environments, with proper gowning.
Ability to safely wear and work in a powered air-purifying respirator hood and associated equipment weighing approximately two to three pounds during assigned tasks.
Ability to perform sustained physical activities, including standing, walking, bending, reaching, lifting, and handling manufacturing equipment while wearing required respiratory protection and personal protective equipment.
Ability to wear and operate a powered air-purifying respirator for extended periods, up to four to six hours per shift, while performing manufacturing, equipment cleaning, and sanitization activities.
Ability to wear required personal protective equipment, including pharmaceutical gowning, respiratory protection, safety glasses, chemical-resistant gloves, and additional protective equipment as required by operational and safety procedures.

Responsibilities

Maintain a daily presence on the production floor to provide real-time quality assurance support and guidance.
Ensure adherence to batch records, standard operating procedures, and validated procedures during manufacturing, packaging, and inspection activities.
Perform quality assurance line clearances, in-process checks, and acceptable quality limit 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, laboratory, and warehouse areas to assess good manufacturing practice compliance and escalate issues as needed.
Verify labeling issuance, reconciliation, and documentation to ensure proper handling of materials and finished products.
Provide on-the-floor coaching and guidance to operators, reinforcing good manufacturing practice 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, out-of-specification, out-of-trend, and corrective and preventive action processes to support investigations if required.
Assist in gathering facts, reviewing documentation, and providing quality assurance input when deviations occur on the floor.
Use root cause analysis tools, including 5 Whys, Fishbone, and failure mode and effects analysis, to support quality discussions.
Review, revise, and proofread good manufacturing practice documentation, including batch records, standard operating procedures, and logbooks.
Support document control processes and ensure training documentation is correctly linked to controlled systems.
Ensure compliance with regulatory standards, including Food and Drug Administration, International Council for Harmonisation, and Drug Enforcement Administration standards, 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.

Desired Qualifications

Familiarity with MasterControl or electronic quality systems.
Experience with automated visual inspection processes.
Knowledge of controlled substance handling.
Prior involvement in regulatory inspections.

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

Preferred Qualifications:

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

Work Environment & Physical Demands

ADA Accommodation Notice

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Requirements

Ability to safely wear and work in a PAPR hood and associated equipment weighing approximately 2 to 3 pounds during assigned tasks.

Ability to perform sustained physical activities, including standing, walking, bending, reaching, lifting, and handling manufacturing equipment while wearing required respiratory protection and personal protective equipment (PPE).

Ability to wear and operate a Powered Air-Purifying Respirator (PAPR) for extended periods, up to 4 to 6 hours per shift, while performing manufacturing, equipment cleaning, and sanitization activities.

Ability to wear required PPE, including pharmaceutical gowning, respiratory protection, safety glasses, chemical-resistant gloves, and additional protective equipment as required by operational and safety procedures

Shifts

2nd shift: 3:00pm - 11:30pm , Monday - Friday

3rd shift: 11:00pm - 7:30am , Sunday - Thursday

Weekend Day shift: 7:00 am - 7:00 pm, Friday - Sunday

At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule – from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.

We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!

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.

About the Company

August Bioservices

US-based CDMO for end-to-end drug development

August Bioservices is a US-based CDMO that provides end-to-end drug development and manufacturing from preclinical to commercial stages. It manages all steps in a single program, including research, development, testing, laboratory services, and sterile fill/finish, while following cGMP standards. It differentiates itself with a hybrid model that combines large-CDMO scale and capabilities with a strong focus on customer service and integrated workflows. Its goal is to help clients bring safe and effective drugs to market efficiently by delivering comprehensive development and manufacturing under one roof.

Company size: 51-200
Company stage: Series B
Total funding: $88.6M
Headquarters: Nashville, TN
Founded: 2017

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