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
$19.00 - $21.00 per hour
Seniority level
Entry level
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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