Inspector; QA Manufacturing - 3rd Shift (11:00PM - 7:30AM)

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