Quality Control Inspector

Company: Swiss American CDMO
Location: Carrollton
Posted on: August 6, 2022

Job Description:

Quality Control Inspector 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 product and complete other duties as required.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 to SAP SOP's and FDA l GMP guidelines.`
--- Assist in execution of product/process validation activities.
--- Collect and analyze appropriate samples for the release testing of finished goods and bulk product (Le. pH and Viscosity).
--- Monitor all activity on the production floor to assure adherence to SAP SOP's and applicable FDA l 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.
--- All other duties and responsibilities assigned.Limits of Authority: Interprets work situations and expectations, handles issues which conform to Company policy and past practice, and refers extraordinary situations to the Quality Control Supervisor or Quality Control Manager for guidance when necessary.Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Education/Experience:High School Diploma or equivalent. Associates degree desired.Language Ability:Must be able to explain processes and effectively implement processes as outlined by SAP protocol.Math Ability:Must be able to understand rounding rules and significant figure rules. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.Reasoning Ability:Must be able to adequately understand SAP protocol and apply to various production processes as it applies to specific procedures. Must be able to deal with a variety situations, including stopping production if the continuation of production would compromise the integrity of the finished good.Computer Skills:To perform this job successfully, an individual should have knowledge of Microsoft Office Business Suite and Internet software.Certificates and Licenses:No certifications neededSupervisory Responsibilities:N/AWork Environment:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.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.

Keywords: Swiss American CDMO, Carrollton , Quality Control Inspector, Other , Carrollton, Texas