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Quality Control Inspector Lead (Production)-QCIP, 2nd Shift (3 p.m.–11 p.m. Daily)

Job Title
Quality Control Inspector Lead (Production)-QCIP, 2nd Shift (3 p.m.–11 p.m. Daily)
Job ID
27314761
Location
CARROLLTON,  TX 75006-6623
Other Location
Description

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 Lead (Production)-QCIP, 2nd Shift (3 p.m.–11 p.m. Daily)

Under the supervision of the Quality Control Supervisor, the Quality Control Inspector Lead Production (QCIP) is responsible for assuring that all products produced at Swiss American Products conform to all regulatory and quality specifications. The QCIP is also responsible for providing job assignments for his/her shift as well as reporting any quality related issues to his/her supervisor.

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.
  • Provide line assignments to all QC inspectors on his/her shift.
  • 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 the execution of product/process validation activities.
  • Collect and analyze appropriate samples for the release testing of finished goods and bulk product (i.e. 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.
  • Provide a daily shift summary of production activities and any issues that may contribute to the manufacture of non-conforming product.
  • Conduct final review of MBR’s prior to submitting to document control for review to ensure that each record is completely and accurately filled out and all activities required by the QC department are fulfilled.

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:

  • Education/Experience: High School Diploma or equivalent; Associates degree desired. 3-5 years working in a quality capacity in a regulated (FDA, USDA) environment.
  • Computer Skills: Knowledge of Microsoft Office Business Suite and Internet software.

Benefits:

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.