Visual Inspection Technician II

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise, and proven regulatory track record.

About the role

The Visual Inspection Technician II is accountable for results in a fast-paced environment and responsible for performing tasks related to the quality inspection of sterile injectable products for commercial distribution and clinical trials. This role involves handling and inspecting manufactured products by following standard operating procedures (SOPs) and batch records in accordance with current Good Manufacturing Practices (cGMPs). The Visual Inspection Technician II also provides training and coaching to less experienced technicians and interacts with customers as needed.

Responsibilities

• Follows applicable SOPs and cGMPs to perform assigned duties and tasks.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Conducts visual inspection of sterile liquids in accordance with regulatory agency guidelines.
• Visually identifies debris, air lines, and other defects in sterile liquids.
• Documents activities in real time on controlled documentation legibly, per SOPs and cGMPs.
• Performs component counting and basic math calculations.
• Performs cleaning of rooms, tools, and equipment.
• Performs specific visual inspections per SOPs.
• Ensures product meets appearance specifications before sending the product for packaging.
• Performs bulk packaging for product vials for shipment to another facility.
• Operates material handling equipment.
• Demonstrates proficiency in all department procedures and trains and coaches other technicians.
• Provides work instruction and oversees daily work assignments in the absence of the supervisor as needed.
• Works occasional hours outside of scheduled shift based on business needs, which may include weekend work.
• Other duties as assigned.

Requirements

• High school diploma or GED required; Associate’s degree preferred.
• 1-2 years of relevant experience required.
• cGMP or prior work experience in a regulated environment preferred.
• Prior pharmaceutical or CDMO experience preferred.

Skills

• 20/20 correctable near-sighted vision in both eyes, tested annually required.
• Ability to see and distinguish colors required.
• Ability to perform basic math calculations, including product accountability calculations and rounding required.
• Ability to read and comprehend detailed written instructions required.
• Ability to move materials throughout the facility using appropriate methods and equipment required.
• Excellent verbal and written communication, documentation, detail orientation, and organizational skills required.
• Ability to train, coach, and develop others required.
• Proficiency in basic computing skills required.
• Awareness of or prior experience with cGMP practices and procedures preferred.

Schedule

100% on-site position. 1st Shift: Monday - Friday, 7:00am - 3:30pm.

Travel Expectations

Up to 5% domestic travel.

Physical Demands and Work Environment

The physical demands and work environment 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.

• Regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear; and smell.
• Frequently required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
• Required to sit for extended periods.
• Must regularly lift and/or move up to 50 pounds with assistance.
• Specific vision abilities required include correctable 20/20 near vision, 20/20 distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
• Frequently exposed to moving mechanical parts, fumes, or airborne particles and toxic or caustic chemicals.
• Occasionally exposed to wet and/or humid conditions, risks of electrical shock, and vibration.
• The noise level in the work environment is usually moderate.
• Required to wear appropriate personal protective equipment (PPE) for specific job duties, which may include safety eyewear, hearing protection, respirators/breathing apparatus, lab coats, full protective body coverings, and various types of gloves.