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Associate, QA Packaging 2

2 months ago

North Brunswick, United States USPL NUTRITIONALS LLC Full time
Job DescriptionJob Description

Job Description

Date

3/2023

Location

1300 Airport Road, North Brunswick NJ

Title

Associate, Quality Assurance 2

Department

Quality Assurance

Reports to

Manager, Quality Assurance

FLSA (Exempt or Non-Exempt

Non-Exempt

Role Overview

This position will be responsible for coordinating quality assurance programs designed to ensure continuous production of products, tracking products and, materials status, and location. Responsible for the issuance and review of batch records, on floor QA inspections, preparation of Master compliance documents, and participating in audit preparations.

This position reports to the Quality Assurance Manager and dotted line to Quality Assurance Supervisor.

This position will help ensure compliance to SOPs, batch records, Master manufacturing records, GMP documentation and to 21 CFR Part 111 and 117.

Areas of Responsibility

  • Prepares Master Compliance Documents such as batch records, and verification documents related to production.
  • Management and Coordination of the sampling, testing, and releasing of raw and packaging materials.
  • Issuance and review of batch records for manufacturing and packaging as required.
  • Perform In-process quality checks for manufacturing and packaging as required.
  • Reads and understands the approved specifications and standards assigned to the project.
  • Performs Line Clearance, Inspection checks, AQL inspections, and coordinates for finished product releases.
  • Performs Sampling of materials as per the procedure’s requirement.
  • Able to read and understand Safety Data Sheets of materials and practices.
  • Maintains a safe and clean environment using PPE, ensures proper safety practices are in use, and identifies any safety or hazard risks.
  • Verification of materials and checking the weights of dispensed materials as per the batch card and procedures requirement.
  • Notifies department Supervisors, Line Leaders, and operators when operations must be terminated due to non-conforming quality conditions.
  • Works extended hours and occasional weekend overtime.
  • Other duties as assigned.

Other Responsibilities Including Safety:

  • Works in a safe and responsible manner to create an injury-free and incident-free workplace.
  • Complies with all job-related safety and other training requirements.
  • Keeps management informed of area activities and of any significant problems.

Requirements

Education & Qualification:

  • High School or BS degree in a life science discipline (e.g., Chemistry, Biochemistry, Microbiology).
  • Minimum of 3+ years’ experience working within a GMP environment within a Nutritional supplement, food, consumer products or pharmaceutical company.

Certifications, Licenses, Credentials:

  • N/A

Skills & Ability

  • Able to work in a team and assist others.
  • Able to perform precisely basic math calculations and follow written instructions.
  • Strong organizational skills, process management, and attention to detail required.
  • Knowledge of warehouse and distribution business processes.
  • Able to follow and understand cGMP’s, OSHA standards etc.
  • Able to distinguish different shades of colors.
  • Intermediate user of MS Office, Excel, Word, Outlook, and ERP systems.
  • Complies with all regulatory in-house requirements (may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP’s, GLP, documentation) when performing the assigned activity.
  • Demonstrates above average written communication skills in the English language to follow the industry regulated instruction sheets.
  • Must be able wear all PPE including lab coat, face mask, shoe covers, gloves, safety glasses.

Work Environment (Office, Warehouse, temperature extremes, etc.):

  • Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employee can be exposed daily to chemicals and cleaning agents.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.