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About the Role

The Inspector, QA Manufacturing ensures product quality throughout all manufacturing phases in accordance with current good manufacturing practices.

Responsibilities

• Perform in-process monitoring of all manufacturing operations.
• Perform duties using good documentation practices.
• Collect in-process and finished product samples.
• Support collection of microbiological samples per procedure.
• Perform room inspections/clearances.
• Perform Batch Record release of both Commercial and IP batch records.
• Perform AQL sampling and inspections.
• Identify and report any non-conformances/discrepancies to management.
• Review general SOPs to ensure production compliance.
• Assist in employee training (initial and ongoing).
• Support environmental monitoring activities.
• Provide additional QA technical support to Coating Department.
• Review batch record documentation.
• Issue QMS forms as required to production.
• Perform daily scale weight verification.
• Maintain QA supplies.
• Review and approve weekly pest control logs.
• Manage sample transmittal to QC and Account Services.
• Review grounds logbook for Maintenance.
• Perform monthly audit of facility fire extinguishers.
• Perform other responsibilities as assigned by Senior Management.

Requirements

• High School or GED diploma required.
• Knowledge of good manufacturing practices and good documentation practices preferred.
• Ability to read, write, and communicate effectively.
• Self-motivated with the ability to work in a fast-paced environment and handle multiple tasks simultaneously.
• Excellent organizational skills with ability to focus on details.
• Required to reach with arms and use hands and fingers to handle or feel objects and tools.
• Required to stoop, kneel, crouch, stand, bend, sit, talk, hear, climb stairs and ladders.
• Must be able to lift and/or move up to 50 pounds.
• Work environment in production operations facilities include close proximity to heavy machinery with loud noises and pharmaceutical powders (dust).
• Potential to move between production operations sites/areas to complete job functions.
• Employee work hours/schedule and/or shift are subject to change based on business needs and Management discretion.
• Work location are subject to change as needed to meet business requirements.
• Gowning as required by GMPs and/or SOPs.
• PPE as needed.

Skills

• Good manufacturing practices
• Good documentation practices
• Effective communication
• Ability to work in a fast-paced environment
• Ability to handle multiple tasks simultaneously
• Organizational skills
• Attention to detail

Work Type

• Full-time

Education Level

• High School or GED diploma

Salary/Compensations

• $21.50 per hour