Visual Inspection Technician
PharmaBiotechClinical ResearchRegulatory AffairsQuality Assurancegmpcdmema
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! The Visual Inspector I role inspects filled sterile and non-sterile products for various defects at the Nashville, TN site. This role contributes to the qualification and start-up of a new manufacturing facility for Aseptic Formulation and Filling to establish a state-of-art manufacturing operation. The Visual Inspector I is responsible for ensuring inspection activities are in compliance with regulatory requirements, Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs). Responsibilities
Visually inspect products for various defects
Document work accurately and contemporaneously on batch records and protocols
Sets-up and operates inspection equipment
Performs line clearance activities
Calculates inspection results and reconciliation of batches
Minimize production downtime through advances troubleshooting skills
Assist Maintenance personnel with Preventive Maintenance and Calibration activities
Communicate with Supervisor, co-workers, managers, and clients in a professional manner
Follow relevant Standard Operating Procedures (SOPs), Work Instructions, etc.
Must be able to work overtime when required Qualifications
Minimum education - High school diploma or equivalent
Basic math skills to perform required batch calculations Knowledge, Skills, & Abilities
Must be able to visually detect defective vials
Must be able to maintain visual inspection qualification requirements
1+ years of experience working in a pharmaceutical or other GMP regulated environment
Previous sterile packaging, clinical trial packaging, or related manufacturing experience is preferred
Good documentation and communication skills and strong attention to detail
Able to work in a team environment
Strong mechanical skills and learning agility
Ability to work in a fast-paced collaborative environment Physical Requirements
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. Prolonged periods sitting at a desk and working on a computer.
Must be able to lift up to 15 pounds at times.
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