QA Associate I, Process Quality Inspector

COATING PLACE LLC•Verona, WI

25d•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

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)

Responsibilities

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.