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:

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