Description:
Position Summary:The Inspector, QA Manufacturing has the primary responsibility of ensuring product quality is maintained through all phases of manufacturing in accordance with current good manufacturing practices.
Responsibilities: Responsibilities include, but are not limited to:
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Perform in-process monitoring (e.g. weight, thickness, hardness, disintegration, friability, etc.) of all manufacturing operations
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Perform duties using good documentation practices
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Collect in-process and finished product samples as required
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Support collection of microbiological samples per procedure as required
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Perform room inspections/clearances as required
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Perform Batch Record release of both Commercial and IP batch records
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Perform AQL sampling and inspections as required
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Identify and report any non-conformances/discrepancies to management if applicable
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Review general SOPs are being met by production
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Assist in employee training (initial and ongoing)
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Support environmental monitoring activities (i.e. water sampling air sampling)
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Provide additional QA technical support to Coating Department
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Review batch record documentation
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QMS form issuance as required to production
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Daily scale weight verification
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Maintain QA supplies
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Review and approve weekly pest control logs
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Sample transmittal to QC and Account Services
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Review grounds logbook for Maintenance
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Monthly audit of facility fire extinguishers
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Other responsibilities as assigned by Senior Management
Requirements:
Education and Experience:
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High School or GED diploma required
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Knowledge of good manufacturing practices and good documentation practices preferred.
Skills, Knowledge and Abilities:
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Ability to read, write, and communicate effectively.
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Self-motivated with the ability to work in fast-paced environment and handle multiple tasks simultaneously.
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Excellent organizational skills with ability to focus on details.
Physical Demands:
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Required to reach with arms and use hands and fingers to handle or feel objects and tools
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Required to stoop, kneel, crouch, stand, bend, sit, talk, hear, climb stairs and ladders
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Must be able to lift and/or move up to 50 pounds
Work Environment:
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Work environment in production operations facilities include close proximity to heavy machinery with loud noises and pharmaceutical powders (dust).
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Potential to move between production operations sites/areas to complete job functions.
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Employee work hours/schedule and/or shift are subject to change based on business needs and Management discretion.
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Work location are subject to change as needed to meet business requirements.
Supervisory Responsibilities:
Personal Protective Equipment or Attire Required for Position:
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Gowning as required by GMPs and/or SOPs
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PPE as needed
Pay Range:
$21.50 per hour
