Visual Inspector Technician

Job Overview:

Responsibilities:

• Assist in various manufacturing activities, related to Visual Inspection as needed.
• Setup, operation, and cleaning of various manufacturing equipment and machines.
• Successful completion of Visual Inspection for CTM batches, Submission batches, PV batches, as well as Commercial manufacturing of various pharmaceutical products with cGMPs per the manufacturing schedule.
• Maintain status labeling and good housekeeping in the department.
• Disposal of waste per applicable SOPs.
• Ability to read, write, and speak English fluently.
• Demonstrates accuracy and thoroughness through documentation. 
• Maintained visual inspection documents and consistently checks all documents for errors and constantly striving for right the first-time mentality.
• Observes safety and security procedures, responsible for meeting department safety objectives.
• Support the engineering team in keeping inspection and/or packaging operation equipment operating efficiently and consistently.
• Ability to pass visual acuity exam according to SOP guidelines.
• Ability to pass visual inspection qualification exams according to SOP guidelines.
• Performing the visual inspection of liquid and lyophilized vials and liquid syringes using manual inspection booths and/or semi-auto machines
• Fulfilling line clearance and cleaning activities of inspection booths and semi-auto inspection machines.
• Assisting with routine product sampling (i.e. AQL) as well as non-routine sampling for various engineering and validation studies
• Supporting the load and unload of inspection equipment and performing Bulk packaging and labeling tasks.
• Perform other duties as assigned.

Qualifications: 

• High School Diploma, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
• Experience as a Manufacturing/Visual Inspector Technician in the pharmaceutical, OTC, or VMS industry. Experience working in the aseptic manufacturing industry is preferred.
• Demonstrate the ability to obtain and maintain gowning qualification, if requested. 
• Must be able to perform calculations using simple mathematical formulas using fractions, percentages, and significant numbers.
• Can accommodate non-routine work schedules, and be able to respond to call-ins, if necessary.
• Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.
• Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
• Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
• Must be able to comprehend and follow all applicable SOPs.
• Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
• Demonstrate ability to acquire the appropriate knowledge from resources on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
• Good understanding of cGMPs, industry, and regulatory standards and guidelines.
• Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
• Demonstrate the ability to portray the appropriate level of integrity and professionalism.
• Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
• Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
• Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
• Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
• Results-oriented and efficient.
• Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
• Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
• Demonstrate the ability to work well in a cross-functional team environment.
• Must communicate fluently in English and have legible handwriting.

Physical Demands: 

• All Visual Inspectors must pass a bi-annual 20/20 near sighted vision screening and color blindness test
• Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
• Ability to lift up to 40 pounds on occasion.
• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).