Batch Record Coordinator
Batch Record Coordinator
Location: Farmingdale, NJ
Employment Type: Full-Time/On Site
Schedule: Mon-Thurs 5:00 AM – 3:30 PM
Pay Rate: $18.50-$20.50
Company Overview:
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 leaders in our field.
Position Description
The Batch Record Coordinator will work in a detail-oriented compliant manner coordinating the batch record flow, correction, proper and complete documentation. Communicating accurate and up-to-date status reviews to appropriate personnel and updating status tracking spreadsheets and preparing reports.
Key Responsibilities
Communicating accurate and up-to-date status reviews to appropriate personnel and updating status tracking spreadsheets and preparing reports.
Assist in the correction of deficiencies found within the documentation reviewed per the cGMPs and SOPs on daily basis.
Ensure documents like batch records, labels, forms, etc. are printed and available for production.
Oversee batch records review and completeness of all associated documentation ensuring compliance with written Policies and procedures as required for batch release.
Perform other assigned duties as may be required in meeting company objectives.
Communicate effectively with other departments within the organization and function within a team environment.
Gather production information to support OOS and Deviation.
Review of specific in-process, and finished product data such as samples data, MES (Inventory Deacom) calculations, EBR completeness, SAP(Deacom) data, and Quality Issues.
Document retrieval from local files and archives, as required for submissions and customer requests.
Assist in process audits and internal audits as needed.
Report Error Weekly Metrics (Right the First Time) Error Free, and success Rate found during review to Management.
Works closely with QA functional teams to align and promote awareness on data integrity and good documentation practices.
Facilitate and Coordinate with Project teams to enhance, improve and streamline batch records cycle time.
Navigate through various online platforms, including Deacom and Smartsheet.
Routine interaction with other departments for purposes of collecting batch record information or working to resolve documentation issues.
Show a desire and willingness to learn and succeed.
Complete all required training activities.
Demonstrate a commitment to the organization by maintaining regular, on-site attendance, act in a reliable manner and follow through on responsibilities.
Other duties as assigned.
Show a desire and willingness to learn and succeed.
Qualifications
2-yr Associates Degree or high school diploma with relevant experience.
Ability to speak, read and write English.
2–5 years of experience in document control, batch record review, quality assurance, or manufacturing documentation.
Experience in a regulated manufacturing environment such as nutraceuticals, pharmaceuticals, food, cosmetics, or medical devices preferred.
Proficiency with Microsoft Office (Excel, Word, Outlook).
Experience with ERP systems (such as Deacom, SAP, or Oracle) is preferred.
Why Join NutraStar?
As a growing leader in the nutraceutical industry, NutraStar offers the opportunity to contribute to high-impact quality initiatives while working in a collaborative and safety-focused environment. You’ll play a vital role in ensuring product quality for customers worldwide.
NutraStar is an equal opportunity employer. Employment at our Company is based solely on job-related qualifications
Pay: $18.50 - $20.50 per hour
Work Location: In person