QA Associate , Process Quality Inspector

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Full-Time, Regular Employee Laborer-Indirect Verona, WI, US

2 days ago Requisition

** New Hires eligible for $2,000 Sign-On Bonus!**

2 nd Shift: 2:00pm – 10:30 pm (Mon-Fri) (Shift Differential = 6% of hourly wage)

* Spanish/English bilingual is a plus, but not required

Position Overview

The QA Associate I, Process Quality Inspector provides quality assurance support and leadership to the Production Department. The QA Associate I, Process Quality Inspector provides a strong floor presence and works directly with production supervision and operators to maintain quality of manufacturing operations.

Essential Job Functions

• Works with Production personnel to ensure compliance of CPI practices, policies, and procedures. A significant focus on batch record and process compliance is expected. Performs routine review of in process production documents during processing to ensure accuracy and completeness.
• Performs routine inspections/audits on personnel, procedures, equipment, and products.
• Provides leadership to Production personnel on quality issues.
• Initiates deviations and documents initial investigations. May contribute to assessment of deviations under the direction of the supervisor.
• Contributes to quality investigations. Serves as lead investigator when assigned by the supervisor.
• Initiates, maintains, and dispositions non-conformances.
• Assists in training of Production personnel in company practices, policies, and procedures.
• Assists in the movement of controlled substances into/out of the controlled substance storage and processing areas.
• Performs sampling activities when assigned by the supervisor.
• Reviews unit logbooks and/or environmental monitoring data as assigned.
• Follows all CPI cGMP practices, policies, and procedures.
• Follows all CPI safety practices, policies, and procedures.
• Employees at CPI work with and/or are familiar with the GMP requirements for Food, Dietary Supplements, Pharmaceuticals, or other elements of each.
• Depending on the position, the employee will be aware of Halal and/or Kosher requirements.
• Other duties as assigned.

Education/Skills/Knowledge Required

• High School diploma or equivalent.
• 2-3 years of industry quality or cGMP manufacturing experience required. Formal quality training may be substituted in place of experience.
• Knowledge of current Good Manufacturing Practices (cGMPs) preferred.
• Knowledge of a variety of cGMP manufacturing practices preferred (including fluid bed coating/granulation, capsule filling, milling, tableting)
• Strong attention to detail and problem-solving skills required.
• Ability to read, write (legibly), and speak the English language at a level necessary for efficient job performance.
• Ability to establish and maintain effective working relationships with team members, co-workers, and/or clients.
• Ability to stand for extended periods of time and lift objects weighing up to 55 lbs.