Associate, QA Documentation 2
U S Pharma Lab Inc U S Pharma Lab Inc North Brunswick, NJ North Brunswick, NJ Full-time Full-time Estimated:
$60.
6K - $76.
7K a year Estimated:
$60.
6K - $76.
7K a year 8 days ago 8 days ago 8 days ago Job Description Date 3/2024 Location 1300 Airport Road, North Brunswick NJ Title Associate II, Quality Assurance - Documentation - Validation Support Department Quality Assurance Reports to VP of Quality Assurance/ Manager QA 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 on floor QA inspections, preparation of Master compliance validation documents and participating in audit preparations.
This position reports to the VP of Quality Assurance and dotted line to Quality Assurance Manager.
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 Preparation of Master Compliance Documents such as Process Validation protocols, Hold Time protocols, summarization of various reports and verification documents related to production.
Preparation and review of Batch Records, Standard Operating Procedures, Quality Manuals, Annual Product Quality review.
Coordinate with different departments Managers Product Development, Production, Maintenance, Quality Control and Quality assurance for approvals of master documents.
Preparation and / or review of equipment qualification documents.
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, in process and finished products as per the validation procedure's requirements.
Submission of validation samples to Internal or external labs.
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 departments Supervisors, Line Leaders, and operators when operations must be terminated due to non-conforming quality conditions.
Initiation and closing of change control, deviation, investigations, CAPA.
Managing and working with Quality compliance audit team to support different audits - internal and external, due diligence and inspection readiness plan.
Works extended hours and occasional weekend overtime.
Other duties as assigned.
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.
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:
Bachelor's Degree ( Science ) preferred 3
years of technical experience working within a GMP environment within a Nutritional supplement, food, consumer products or pharmaceutical company.
Or equivalent combination of education and experience.
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 an 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 to wear all PPE including lab coat, face mask, shoe covers, gloves, safety glasses.
Physical Requirements (lifting, etc.
):
The employee is frequently required to sit (50%), stand, and walk (50%).
Uses hands to finger, handle or feel writing tools and computer keyboard.
May reach with hands and arms and infrequently may lift to 30lbs.
Use desk telephone/cell phone to talk and hear or converse with other employees.
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.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
$60.
6K - $76.
7K a year Estimated:
$60.
6K - $76.
7K a year 8 days ago 8 days ago 8 days ago Job Description Date 3/2024 Location 1300 Airport Road, North Brunswick NJ Title Associate II, Quality Assurance - Documentation - Validation Support Department Quality Assurance Reports to VP of Quality Assurance/ Manager QA 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 on floor QA inspections, preparation of Master compliance validation documents and participating in audit preparations.
This position reports to the VP of Quality Assurance and dotted line to Quality Assurance Manager.
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 Preparation of Master Compliance Documents such as Process Validation protocols, Hold Time protocols, summarization of various reports and verification documents related to production.
Preparation and review of Batch Records, Standard Operating Procedures, Quality Manuals, Annual Product Quality review.
Coordinate with different departments Managers Product Development, Production, Maintenance, Quality Control and Quality assurance for approvals of master documents.
Preparation and / or review of equipment qualification documents.
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, in process and finished products as per the validation procedure's requirements.
Submission of validation samples to Internal or external labs.
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 departments Supervisors, Line Leaders, and operators when operations must be terminated due to non-conforming quality conditions.
Initiation and closing of change control, deviation, investigations, CAPA.
Managing and working with Quality compliance audit team to support different audits - internal and external, due diligence and inspection readiness plan.
Works extended hours and occasional weekend overtime.
Other duties as assigned.
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.
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:
Bachelor's Degree ( Science ) preferred 3
years of technical experience working within a GMP environment within a Nutritional supplement, food, consumer products or pharmaceutical company.
Or equivalent combination of education and experience.
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 an 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 to wear all PPE including lab coat, face mask, shoe covers, gloves, safety glasses.
Physical Requirements (lifting, etc.
):
The employee is frequently required to sit (50%), stand, and walk (50%).
Uses hands to finger, handle or feel writing tools and computer keyboard.
May reach with hands and arms and infrequently may lift to 30lbs.
Use desk telephone/cell phone to talk and hear or converse with other employees.
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.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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