Job Description Job Description
New Hires eligible for $2,000 Sign-On Bonus!
2nd 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.
