August Bioservices, LLC · 2 days ago
Quality Assurance Operations Lead
Nashville, TN
Full-time
Onsite
Mid Level
4+ years expAugust Bioservices is a high-growth Contract Development Manufacturing Organization (CDMO) based in Nashville, TN, focusing on drug discovery and manufacturing services for the pharmaceutical industry. The Quality Assurance Operations Lead will be responsible for developing and overseeing the Quality Assurance AQL Visual Inspection program, ensuring compliance with cGMP and regulatory requirements while interacting with various levels of the company in a dynamic environment.
BiotechnologyMedicalPharmaceutical
Responsibilities
Implement, coordinate, administer, and continuously improve the Quality Assurance AQL Visual Inspection / On-The-Floor program:
Responsible for development and quality oversight of the visual inspection /quality on the floor program
Partners with manufacturing and other internal groups to establish a philosophy for visual inspection and develops the visual inspection qualification for operators and QA AQL Specialists
Builds and maintains qualification kits
Collaborates with manufacturing to develop the program for classification of rejects and AQL levels
Participates in equipment design and start-up of automated equipment and manual/semi-manual visual inspection start up
Supports implementation / qualification of automated inspection procedures
Reviews all SOPs, policies, work instructions, batch records, etc. regarding visual inspection, defects, rejects, and defect kits
Develops QA documents for visual inspection AQL inspection
Quality reviewer/approver for visual inspection deviations, change controls, CAPAs, etc
Completes training and maintains required qualifications for visual inspections
Responsible for performing QA line clearance for visual inspection and audits of the fill/finish area
Analyzes and trends AQL defects, provides metrics, and presents KPIs
Reviews and approves process generated data from manufacturing visual inspection
Ensure regular presence in operational areas and support personnel on quality matters
Real-time batch record reviews and in-process auditing
Routine walk-throughs of production areas, laboratories, and warehouse to ensure inspection readiness of the facility. Routinely communicate findings and ensure issues are corrected in a timely manner
Ensures processes are executed according to batch records and procedures. Ensures any potential compliance issues identified during batch record review are corrected and clarified
Provides constructive feedback to individuals executing batch records and communicates best practices to share with different areas of manufacturing
Collaborates with planning groups to prioritize critical lot disposition. Also ensures that the schedule is being monitored and operations has all the required releases to ensure no downtime
Identifies process improvements of batch record review and product disposition processes
Oversees labeling activities, verifies labeling issued to and returned from operations
Immediately escalates issues to QA management, submits event notifications where appropriate
Ability to assess and triage deviations that occur with the local process team. Write, review, and assess deviations, and participate in investigations. Support CAPAs, gap analysis, and product complaints
Develops strategy on how to achieve the work that needs to be completed, works with manufacturing to determine schedule and support. Ensures appropriate coverage which may include some evenings
Provide support during internal / external / regulatory inspections
Adhere to company policies and applicable regulatory agencies requirements (ICH, FDA etc.) to ensure compliance
Communicate clearly with cross-functional teams
Train and qualify future QA AQL Specialists
Other duties as assigned
Qualification
Required
Bachelor's degree in science or other related discipline, or equivalent level of skill and experience
A minimum of 4 years of AQL inspection experience in the pharmaceutical industry with liquid and lyophilized products
Highly organized individual with strong attention to detail
Ability to management time and priorities effectively
Preferred
Quality Engineer Certification
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