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    QA Manufacturing - Hauppauge, United States - Contract Pharmacal

    Contract Pharmacal
    Contract Pharmacal Hauppauge, United States

    2 weeks ago

    Default job background
    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:
    • Perform in-process monitoring (e.g. weight, thickness, hardness, disintegration, friability, etc.) of all manufacturing operations
    • Perform duties using good documentation practices
    • Collect in-process and finished product samples as required
    • Support collection of microbiological samples per procedure as required
    • Perform room inspections/clearances as required
    • Perform Batch Record release of both Commercial and IP batch records
    • Perform AQL sampling and inspections as required
    • Identify and report any non-conformances/discrepancies to management if applicable
    • Review general SOPs are being met by production
    • Assist in employee training (initial and ongoing)
    • Support environmental monitoring activities (i.e. water sampling air sampling)
    • Provide additional QA technical support to Coating Department
    • Review batch record documentation
    • QMS form issuance as required to production
    • Daily scale weight verification
    • Maintain QA supplies
    • Review and approve weekly pest control logs
    • Sample transmittal to QC and Account Services
    • Review grounds logbook for Maintenance
    • Monthly audit of facility fire extinguishers
    • Other responsibilities as assigned by Senior Management
    Requirements

    Education and Experience:
    • High School or GED diploma required
    • Knowledge of good manufacturing practices and good documentation practices preferred.
    Skills, Knowledge and Abilities:
    • Ability to read, write, and communicate effectively.
    • Self-motivated with the ability to work in fast-paced environment and handle multiple tasks simultaneously.
    • Excellent organizational skills with ability to focus on details.
    Physical Demands:
    • 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:
    • 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.
    Supervisory Responsibilities:
    • None
    Personal Protective Equipment or Attire Required for Position:
    • Gowning as required by GMPs and/or SOPs
    • PPE as needed
    Pay Range:

    $ $21.00 per hour
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