Apply 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 operationsPerform duties using good documentation practicesCollect in-process and finished product samples as requiredSupport collection of microbiological samples per procedure as requiredPerform room inspections/clearances as requiredPerform Batch Record release of both Commercial and IP batch recordsPerform AQL sampling and inspections as requiredIdentify and report any non-conformances/discrepancies to management if applicableReview general SOPs are being met by productionAssist in employee training (initial and ongoing)Support environmental monitoring activities (i.e. water sampling air sampling)Provide additional QA technical support to Coating DepartmentReview batch record documentationQMS form issuance as required to productionDaily scale weight verificationMaintain QA suppliesReview and approve weekly pest control logsSample transmittal to QC and Account ServicesReview grounds logbook for MaintenanceMonthly audit of facility fire extinguishersOther responsibilities as assigned by Senior Management Requirements

Education and Experience:

High School or GED diploma requiredKnowledge 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 toolsRequired to stoop, kneel, crouch, stand, bend, sit, talk, hear, climb stairs and laddersMust 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 SOPsPPE as needed

Pay Range:

$19.00 - $21.00 per hour