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Pharmaceutics International Inc

Visual Inspector Technician- 2nd Shift

Pharmaceutics International Inc, Maryland Line, Maryland, us, 21105


Job Overview:

Responsible for the setup, operation, control, monitoring, and cleaning of various manufacturing equipment.

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 machinesFulfilling 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 studiesSupporting 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 testAbility 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).