Inspector; QA Manufacturing - 1st Shift (7:30AM - 4:00PM)

Contract Pharmacal Corp; Hauppauge (NY); On-site; USD 23,000 - 32,000; Full time

Job summary

Contract Pharmacal Corp. is seeking an Inspector for QA Manufacturing to ensure product quality across all manufacturing stages in compliance with current GMP.

Responsibilities include in-process monitoring (weight, disintegration, hardness, etc.), sampling, batch record review, non-conformances reporting, and assisting in employee training. Work hours may vary based on production needs at Hauppauge, NY.

Qualifications

• High School or GED diploma required.
• Knowledge of good manufacturing practices and good documentation practices preferred.
• 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.

Responsibilities

• 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.

Skills

Reading & writing

Communication

Organizational skills

Multi-tasking

Education

High School diploma

GED

Job 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

• 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:

$20.00 per hour