{"id":2467529,"url":"https://alion.io/job/august-bioservices-quality-assurance-lead-3rd-shift","title":"Quality Assurance Lead (3rd Shift)","company":{"id":3783650,"name":"August Bioservices","domain":"augustbio.com","url":"https://alion.io/company/augustbio","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":{"grade":"C","score":67,"open_postings":26,"ghost_share":0.462,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":95,"computed_at":"2026-11-02T06:13:15Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Nashville, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":102000,"max_usd":206000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":1961},"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2022-02-22T19:04:51Z","employer_posted_date":"2022-02-22","last_verified_at":"2026-11-02T19:51:16Z","board_verified":true,"closed_at":null,"days_open":1714,"trust":{"level":"ghost","repost_count":0,"flags":["stale","company_stale"],"days_open":1713},"description":"The Quality Assurance Operations, Quality Assurance is responsible for supporting Quality Assurance Operations at August Bioservices. This position is the lead for QA AQL Visual Inspection and on the floor quality. This position is new to August Bioservices and will be responsible for developing the program to ensure Quality Compliance oversight with cGMP, Regulatory, and Internal requirements regarding the manufacture, testing, and distribution of products through real-time, continuous on the floor presence. This role will interact with all levels of the company in a fast paced and growing environment.\nResponsibilities\nImplement, coordinate, administer, and continuously improve the Quality Assurance AQL Visual Inspection / On-The-Floor program:\nResponsible for development and quality oversight of the visual inspection /quality on the floor program. \nPartners 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.\nBuilds and maintains qualification kits.\nCollaborates with manufacturing to develop the program for classification of rejects and AQL levels.\nParticipates in equipment design and start-up of automated equipment and manual/semi-manual visual inspection start up.\nSupports implementation / qualification of automated inspection procedures.\nReviews all SOPs, policies, work instructions, batch records, etc. regarding visual inspection, defects, rejects, and defect kits.\nDevelops QA documents for visual inspection AQL inspection.\nQuality reviewer/approver for visual inspection deviations, change controls, CAPAs, etc.\nCompletes training and maintains required qualifications for visual inspections.\nResponsible for performing QA line clearance for visual inspection and audits of the fill/finish area.\nAnalyzes and trends AQL defects, provides metrics, and presents KPIs.\nReviews and approves process generated data from manufacturing visual inspection.\nEnsure regular presence in operational areas and support personnel on quality matters.\nReal-time batch record reviews and in-process auditing.\nRoutine 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.\nEnsures processes are executed according to batch records and procedures. Ensures any potential compliance issues identified during batch record review are corrected and clarified. \nProvides constructive feedback to individuals executing batch records and communicates best practices to share with different areas of manufacturing.\nCollaborates 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.\nIdentifies process improvements of batch record review and product disposition processes. \nOversees labeling activities, verifies labeling issued to and returned from operations. \nImmediately escalates issues to QA management, submits event notifications where appropriate.\nAbility 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. \nDevelops 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. \nProvide support during internal / external / regulatory inspections.\nAdhere to company policies and applicable regulatory agencies requirements (ICH, FDA etc.) to ensure compliance.\nCommunicate clearly with cross-functional teams.\nTrain and qualify future QA AQL Specialists\nOther duties as assigned\nRequirements\nBachelor’s degree in science or other related discipline, or equivalent level of skill and experience\nA minimum of 4 years of AQL inspection experience in the pharmaceutical industry with liquid and lyophilized products\nQuality Engineer Certification preferred\nHighly organized individual with strong attention to detail\nAbility to management time and priorities effectively\nPhysical Requirements\nADA Accommodation Notice\nThe 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.\nPhysical Requirements\nAbility to safely wear and work in a PAPR hood and associated equipment weighing approximately 2 to 3 pounds during assigned tasks.\n\nAbility 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).\n\nAbility 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.\n\nAbility to wear required PPE, including pharmaceutical gowning, respiratory protection, safety glasses, chemical-resistant gloves, and additional protective equipment as required by operational and safety 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