Inspection & Packaging Reject Verifier
Build your future at Curia, where our work has the power to save lives. Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.
Benefits
- Generous benefit options (eligible first day of employment)
- Paid training, vacation, and holidays (vacation accrual begins on first day of employment)
- Career advancement opportunities
- Education reimbursement
- 401K program with matching contributions
- Learning platform
About the role
The Inspection & Packaging Reject Verifier performs inspection and packaging operations while serving as the subject matter expert for reject verification, defect identification, and classification in accordance with established Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP). This role evaluates products requiring further review, completes all required reject verification documentation, and trains and qualifies inspection personnel on defect recognition and inspection procedures. The Reject Verifier collaborates with cross-functional teams to support investigations, process improvements, customer interactions, and regulatory audits while ensuring product quality, compliance, and operational excellence.
Responsibilities
- Performs inspection and packaging activities when not assigned to reject verification or other designated responsibilities.
- Maintains qualification to perform inspection activities in accordance with applicable SOPs.
- Evaluates "Further Review" vials identified during 100% inspection and determines defect classification in accordance with established SOPs.
- Completes all required documentation related to defect identification and disposition, including Reject Verification Inspection (RVI) forms, batch production records (PBRs), and other applicable records.
- Communicates reject verification results to management and promptly escalates issues through verbal communication and written correspondence, as appropriate.
- Collaborates effectively with cross-functional departments to support production and quality objectives.
- Captures and maintains photographic documentation of defects for use in defect libraries, training materials, customer communications, and presentations.
- Provides training and guidance to inspection personnel on defect identification during online inspection and communicates defect trends and performance concerns to the Line Lead and/or Supervisor.
- Trains new and existing employees on inspection processes, qualification requirements, and other departmental procedures and training programs.
- Supports the execution of annual inspection qualification testing.
- Assists with departmental projects and initiatives related to inspection processes, defect identification, and continuous process improvement.
- Serves as a subject matter expert in reject identification and classification by supporting customer inquiries and technical discussions, as needed.
- Presents reject verification processes, responsibilities, and performance during customer meetings and regulatory or client audits.
- Assists with quality investigations and the implementation of process-related corrective and preventive actions (CAPAs).
- Promotes a culture of continuous improvement by identifying opportunities to enhance operational efficiency, product quality, and process effectiveness.
- Leads or supports departmental projects and ensures assigned initiatives are successfully managed through completion.
- Reads and interprets SOPs to ensure compliance.
- Performs other duties as assigned.
Requirements
- High school diploma or general education degree (GED).
- Minimum one (1) year of related experience in production or manufacturing, preferred.
- Minimum one (1) year of clean room experience, preferred.
- Ability to read and interpret documents such as safety instructions, standard operating procedures, policies, and manuals.
- Ability to write clearly and communicate effectively.
- Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, decimals, and percentages.
- Ability to draw and interpret bar graphs.
- Demonstrates understanding and effective application of written and oral instruction.
- Skilled in Microsoft Word, Excel, and Outlook.
- Ability to quickly adapt and learn new manufacturing software systems.
- Fosters a collaborative and positive work environment.
- Champions change.
- Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.
- Demonstrates strong attention to detail.
- Meets or exceeds visual acuity, depth perception, and color requirements.
- Must receive passing test results on vision, color blindness, and depth perception eye exam.
- Must have clear vision: up close (20 inches or less), at distance (20 feet or more), color (ability to identify and distinguish colors), depth perception (three-dimensional vision, ability to judge distances and spatial relationships), adjust focus (ability to adjust the eye to bring an object into sharp focus), and peripheral (ability to observe an area that can be seen up and down or left to right while eyes are fixed on a given point).
- Must pass a background check.
- Must pass a drug screen.
- May be required to pass Occupational Health Screening.
- Must pass initial and annual vision test.
Physical Demands
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.
- Regular or occasional lifting, pushing, and pulling up to 10 pounds frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently.
- Regular sitting, standing, and reaching, with some roles requiring prolonged periods of time for each activity.
- Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents.
- Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons.
- Occasional stooping, kneeling, twisting, crouching, crawling, and balancing.
- Certain roles may involve climbing and working at elevated heights.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- The employee may be required to work in an office, manufacturing, or warehouse environment.
- The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background.
- The pharmaceutical manufacturing environment is sterile, requiring aseptic gowning. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes, and powered air purifying respirators) is necessary, depending upon the task at hand.
- Exposure to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.
- The warehouse environment is typically set at a controlled temperature but may involve exposure to refrigerator or freezer temperatures when retrieving materials.
- Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities, and vibration.
- Some positions may work with or be exposed to compressed gases and must wear ear protection.
- All environments may be subject to working with or being exposed to cleaning agents.