Inspector; QA Manufacturing
2 weeks ago
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
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:
$18.00 - $20.00 per hour
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