Visual Inspection Technician 1

 

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.

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Job Summary

The Visual Inspection Technician I is accountable for results in a fast-paced environment and responsible to perform tasks for the quality inspection of sterile injectable products for commercial distribution and clinical trials. The Visual Inspection Technician handles and inspects manufactured products by following standard operation procedures (SOPs) and batch records in accordance with current Good Manufacturing Practices (cGMPs). In addition, the Visual Inspection Technician employs acceptable techniques while working in manufacturing environments, including PPE gowning.

On-Site Expectations

• 100% on-site position.
• 2nd Shift: Monday - Friday, 2:00pm - 10:30pm.

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 and 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.

• Works occasional hours outside of scheduled shift based on business needs, which may include weekend work.

• Other duties as assigned.

Qualifications

• High school diploma or GED required. Associate degree preferred.
• Entry level, 1+ years of relevant work experience strongly preferred OR BioWork certification from an accredited institution.
• Relevant work experience in roles with visual inspection in regulated environments (i.e. medical field, electronics, aerospace, automotive production) are applicable. 
• cGMP or prior work experience in a regulated environment preferred.
• Prior pharmaceutical or CDMO experience preferred.

Knowledge, Skills, and Abilities

• 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.
• Proficiency in basic computing skills required.
• Awareness of or prior experience with cGMP practices and procedures preferred.

Travel Expectations

• Up to 5% domestic travel.

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met or encountered 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. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch or crawl. The employee is required to sit for extended periods. The employee must regularly lift and/or move up to 50 pounds with assistance. Specific vision abilities required by this job include correctable 20/20 near vision, 20/20 distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions, risks of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.