Quality Control Release Specialist in Farmingdale, New Jersey at NutraStar Inc
NewSalary: $65000 - $70000Job Function: Admin/Clerical/Secretarial
NutraStar Inc
Farmingdale, New Jersey, 07727, United States
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Job Description
Quality Control Release Specialist
Location: Farmingdale, NJ
Employment Type: Full-Time/On Site
Schedule: Mon-Thurs 8:00 AM - 5:00 PM, Fri 8:00 AM - 2:00 PM
Pay Rate: $65,000.00 - $70,000.00 Hourly
Hour Per Week: 40 hours per week
NutraStar is a fast-growing contract manufacturer specializing in the formulation and production of high-quality nutraceuticals. With more than 300 employees and a reputation built on customer service, precision, quality, and innovation, we serve some of the most respected brands in the health and wellness industry. Our continued investment in people, technology, and infrastructure drives our rapid growth and positions us as a leader in our field
About the role
The Quality COA Specialist plays a critical role in ensuring the quality and compliance of products and services by preparing, reviewing, and maintaining accurate and complete Certificates of Analysis (COAs) and Batch Production Records (BPRs) for manufactured batches in accordance with cGMP. This role involves collaborating with various departments to ensure that COAs are generated and maintained in accordance with industry standards and company policies. In addition to performing the QA review of batch records for final products and reviews and evaluates QC data to ensure that lots meet applicable cGMP requirements prior to release.
Key Responsibilities:
• Prepare and review COAs for various products and services, ensuring accuracy, completeness, and compliance with relevant regulations and standards.
• Gather and analyze data from testing and inspection activities to support COA generation. •
• Maintain a comprehensive understanding of product specifications, testing protocols, and acceptable limits.
• Conduct routine inspections and quality checks to ensure products meet established quality standards.
• Maintain accurate and organized records of COAs, test results, and other relevant documentation.
• Ensure QA checklist is adequate and comprehensive to enable batch disposition
• Writes, reviews and revises SOPs as required
• Perform duties as assigned by QA Management
• Collaborate with other departments, including production, laboratory, and sales, to ensure smooth COA processes.
• Prepare and present quality reports and summaries to management and other stakeholders.
• Communicate quality issues and concerns effectively to relevant personnel.
• Strong Communication, both verbal and written
• Flexible and open to change
• Team skills and tolerance
• Attention to detail.
• Patience and the ability to remain calm in stressful situations.
• Ability to work well with others.
• Must be able to read, analyse and review batch records and lab reports.
• Process Improvement approach to responsibilities
Qualifications
• Bachelor’s degree (preferred) in Food Science or related field.
• 2+ years’ experience in GMP or FDA regulated industry.
• Basic math and computer skills.
• Ability to work as part of team and adapt to changes in work duties.
• Detail-oriented, thorough, and methodical, and able to follow timeline.
• Ability to handle multiple tasks and priorities with excellent time management.
• Must be able to influence others without authority.
Additional Requirements
• Proficiency in a specific laboratory software or data analysis tool.
• Microsoft Office Suite, Outlook
• Trained and well versed on the DEACOM (ERP) application.
• 21 CFR 111 cGMP in Manufacturing, Packaging, or Holding Operations for Dietary Supplements
• FSSC 22000 Food Safety Management System
• 7 CFR 205 National Organic Program (NOP)
Why Join NutraStar?
NutraStar is an equal opportunity employer. Employment at our Company is based solely on job-related qualifications: we recruit, hire, train, promote and compensate our employees and provide all other conditions of employment including company sponsored events without regard to race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or gender including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances (referred to as “protected characteristics”). Employment actions are based upon our operating needs and individual employee or applicant merit, including but not limited to: qualifications, experience, ability, availability, cooperation and job performance.
Statements in this job description are not intended to be an exhaustive list of all duties, responsibilities, and skills required. Management maintains the right to assign or reassign duties and responsibilities to this job at any time. The Physical Requirements and Working Conditions section are intended to describe the nature of work and the minimum requirements of the job in general. Physical Requirements and Working Conditions based on product(s) handled, equipment used and customer requirements.
Location: Farmingdale, NJ
Employment Type: Full-Time/On Site
Schedule: Mon-Thurs 8:00 AM - 5:00 PM, Fri 8:00 AM - 2:00 PM
Pay Rate: $65,000.00 - $70,000.00 Hourly
Hour Per Week: 40 hours per week
NutraStar is a fast-growing contract manufacturer specializing in the formulation and production of high-quality nutraceuticals. With more than 300 employees and a reputation built on customer service, precision, quality, and innovation, we serve some of the most respected brands in the health and wellness industry. Our continued investment in people, technology, and infrastructure drives our rapid growth and positions us as a leader in our field
About the role
The Quality COA Specialist plays a critical role in ensuring the quality and compliance of products and services by preparing, reviewing, and maintaining accurate and complete Certificates of Analysis (COAs) and Batch Production Records (BPRs) for manufactured batches in accordance with cGMP. This role involves collaborating with various departments to ensure that COAs are generated and maintained in accordance with industry standards and company policies. In addition to performing the QA review of batch records for final products and reviews and evaluates QC data to ensure that lots meet applicable cGMP requirements prior to release.
Key Responsibilities:
• Prepare and review COAs for various products and services, ensuring accuracy, completeness, and compliance with relevant regulations and standards.
• Gather and analyze data from testing and inspection activities to support COA generation. •
• Maintain a comprehensive understanding of product specifications, testing protocols, and acceptable limits.
• Conduct routine inspections and quality checks to ensure products meet established quality standards.
• Maintain accurate and organized records of COAs, test results, and other relevant documentation.
• Ensure QA checklist is adequate and comprehensive to enable batch disposition
• Writes, reviews and revises SOPs as required
• Perform duties as assigned by QA Management
• Collaborate with other departments, including production, laboratory, and sales, to ensure smooth COA processes.
• Prepare and present quality reports and summaries to management and other stakeholders.
• Communicate quality issues and concerns effectively to relevant personnel.
• Strong Communication, both verbal and written
• Flexible and open to change
• Team skills and tolerance
• Attention to detail.
• Patience and the ability to remain calm in stressful situations.
• Ability to work well with others.
• Must be able to read, analyse and review batch records and lab reports.
• Process Improvement approach to responsibilities
Qualifications
• Bachelor’s degree (preferred) in Food Science or related field.
• 2+ years’ experience in GMP or FDA regulated industry.
• Basic math and computer skills.
• Ability to work as part of team and adapt to changes in work duties.
• Detail-oriented, thorough, and methodical, and able to follow timeline.
• Ability to handle multiple tasks and priorities with excellent time management.
• Must be able to influence others without authority.
Additional Requirements
• Proficiency in a specific laboratory software or data analysis tool.
• Microsoft Office Suite, Outlook
• Trained and well versed on the DEACOM (ERP) application.
• 21 CFR 111 cGMP in Manufacturing, Packaging, or Holding Operations for Dietary Supplements
• FSSC 22000 Food Safety Management System
• 7 CFR 205 National Organic Program (NOP)
Why Join NutraStar?
NutraStar is an equal opportunity employer. Employment at our Company is based solely on job-related qualifications: we recruit, hire, train, promote and compensate our employees and provide all other conditions of employment including company sponsored events without regard to race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or gender including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances (referred to as “protected characteristics”). Employment actions are based upon our operating needs and individual employee or applicant merit, including but not limited to: qualifications, experience, ability, availability, cooperation and job performance.
Statements in this job description are not intended to be an exhaustive list of all duties, responsibilities, and skills required. Management maintains the right to assign or reassign duties and responsibilities to this job at any time. The Physical Requirements and Working Conditions section are intended to describe the nature of work and the minimum requirements of the job in general. Physical Requirements and Working Conditions based on product(s) handled, equipment used and customer requirements.
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Job Location
Farmingdale, New Jersey, 07727, United States
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