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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:

$23.00 per hour