Swiss American CDMO LLC is a topical drug and medical device manufacturing company founded to provide cutting-edge topical skin care technologies to selected markets. Our business strategy consists of development, manufacturing and superior customer service to contract manufacturing customers worldwide. A strong team approach to serve our customers is the basis of our mantra – “Partnering to deliver service through quality, integrity and commitment.” Are you passionate about Service Excellence, Results, Integrity and Leadership? These are the core attributes we are looking for at Swiss-American CDMO, LLC.
Quality Control Inspector (Compounding), 2nd Shift (2 p.m.-10 p.m. Daily)
Under the supervision of the Quality Control Supervisor, the Quality Control Inspector (QCI) is responsible for assuring that all products produced at Swiss American Products conform 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 FDAlGMP guidelines.
- Assist in the 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 FDAlGMP 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.
- 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.
- 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 of situations, including stopping production if the continuation of production would compromise the integrity of the finished good.
- Computer Skills: Knowledge of Microsoft Office Business Suite and Internet software.
We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive annual salary, an extensive benefits package including paid time off, medical, dental and vision benefits, 401K plan with company match and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning, and culture.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Product Quality Assurance
Corrective And Preventive Action (Capa)
Quality Control System