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

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

HAUPPAUGE, NY (http://maps.google.com/maps?q=160+COMMERCE+DRIVE+HAUPPAUGE+NY+USA+11788)

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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