JOB DESCRIPTION –
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.
• Other duties as assigned.
Education/Skills/Knowledge Required
• High school diploma or equivalent required.
• 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.
Competitive Benefits:
• Medical, Dental, Vision, Life, AD&D, and Disability Insurance
• 401K Plan
• Tuition Reimbursement Program
• Paid-time Off - Accrue up to 17 days of PTO within the 1st year!
