QA Manufacturing - 2nd Shift (4:00PM - 12:30AM) - Contract Pharmacal : Job Details

QA Manufacturing - 2nd Shift (4:00PM - 12:30AM)

HAUPPAUGE, NY (

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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:

$19.00 - $21.00 per hour