What are the responsibilities and job description for the Quality Control Inspector position at Swiss American CDMO?
Position Summary: Under supervision of the Quality Control Supervisor, the Quality Control Inspector (QCI) is responsible for assuring that all products produced at Swiss American Products conforms to all regulatory and quality specifications. In doing so, the QCI will monitor production, test bulk compounded products and complete other duties as required.
Essential Duties And Responsibilities
Essential Skills and Qualifications:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate.
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. Must be able to lift up to 50lbs on a regular basis.
The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. Employees will be required to perform overtime (OT) duties as requested by their manager.
Essential Duties And Responsibilities
- Perform pre-production line inspections to ensure that all manufacturing lines are clear of materials from previous runs and is acceptable for use.
- Complete routine production line checks to check and accurately document finished good product for fill weights, visual conformity, and/or seal inspection
- Collect, document and prepare samples for shipment for microbial and chemical testing.
- Ensure that all operations in production areas are performed in accordance with SAP SOP's and FDA/GMP guidelines.
- Assist in execution of product/process validation activities.
- Collect and analyze appropriate samples for the release testing of finished goods and bulk products (Le. pH and Viscosity).
- Monitor all activity on the production floor to assure adherence to SAP SOP's and applicable FDA/GMP regulations.
- Participate in investigations for process deviations and product quality failures and assist in implementation of corrective actions.
- Print and release finished good case labels to production personnel.
- Other duties may be assigned
Essential Skills and Qualifications:
- High School Diploma or equivalent required.
- Associate's degree in a relevant field (e.g., Science, Engineering, Quality Control) preferred.
- Excellent verbal and written communication skills.
- Ability to clearly and effectively communicate findings and recommendations.
- Strong analytical and problem-solving skills with the ability to analyze data and draw conclusions.
- Understanding of mathematical concepts such as rounding, significant figures, fractions, percentages, ratios, and proportions.
- Ability to interpret and apply complex procedures and protocols (e.g., SAP).
- Strong decision-making and judgment skills with the ability to identify and address quality issues promptly.
- Ability to independently identify and resolve quality-related problems.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
- Familiarity with relevant quality control software and databases.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate.
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. Must be able to lift up to 50lbs on a regular basis.
The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. Employees will be required to perform overtime (OT) duties as requested by their manager.