August Bioservices, LLC · 1 month ago
QA Specialist - On the Floor Support (3rd Shift)
Nashville, Tennessee
Full-time
Onsite
Entry, Mid Level
2+ years expAugust Bioservices is a high-growth Contract Development Manufacturing Organization based in Nashville, TN, focused on providing drug discovery and manufacturing services to the pharmaceutical industry. The QA Specialist role involves ensuring cGMP compliance and providing real-time quality oversight across manufacturing operations while promoting a strong quality culture.
BiotechnologyMedicalPharmaceutical
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
Qualification
Required
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
Strong communication, problem-solving, and interpersonal skills
Ability to work flexible shifts, including evenings or weekends as required
Preferred
Familiarity with Master Control or electronic quality systems
Experience with automated visual inspection processes
Knowledge of controlled substance handling
Prior involvement in regulatory inspections
Company
August Bioservices, LLC
August Bioservices, a leading sterile injectable CDMO headquartered in Nashville, Tennessee, delivers end-to-end contract development and manufacturing services for pharmaceutical and biotech clients.
51-200 employees
H1B Sponsorship
August Bioservices, LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (15)
2024 (11)
2023 (12)
2022 (2)
2021 (4)
Funding
Current Stage
Growth StageTotal Funding
$88.6MKey Investors
Oak HC/FTPolaris Partners
2022-12-01Series B· $65M
2021-05-27Series A· $23.6M
2020-07-16Series Unknown
Leadership Team
Mats Bjoerkman
Chief Financial Officer
Colette Lanzon
Talent Acquisition Business Partner
Recent News
Seattle TechFlash
2025-06-24
The Business Journals
2024-02-11
Company data provided by crunchbase