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QA Manufacturing

2 months ago

Hauppauge, United States CONTRACT PHARMACAL CORP Full time $19 - $21
Job DescriptionJob DescriptionDescription:

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:

$19.00 - $21.00 per hour