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

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