What are the responsibilities and job description for the Batch Records Coordinator - Manufacturing position at NutraStar Inc.?
Position Description:
The Batch Record Coordinator plays a critical role in ensuring the accuracy and completeness of production batch records. This role involves the meticulous review of batch records, identification and initiation of yield deviations, and management of the deviation process from initiation through resolution. The Coordinator will work closely with production, quality assurance, and other relevant departments to support operational excellence and compliance with all regulatory and company standards.
Key Responsibilities:
- Conduct detailed reviews of completed production batch records to ensure accuracy, completeness, and compliance with company standards and regulatory requirements.
- Identify discrepancies in production yield, initiate deviation reports, investigate root causes, and collaborate with cross-functional teams to ensure corrective actions are implemented.
- Accurately document all findings, deviations, and corrective actions in a timely manner, ensuring alignment with regulatory requirements and internal policies in Qt9 (electronic Quality Management System).
- Work with the production team to identify trends and recommend process improvements to minimize yield deviations and enhance operational efficiency.
- Provide guidance and training to production staff on proper documentation practices and adherence to batch record protocols to support continuous compliance.
- Partner with Quality, Production, and Operations teams to communicate deviations, resolve issues, and improve the overall production process
- 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.
Education/Experience:
- Manufacturing environment experience in batch record review or production documentation preferred.
- Ability to speak, read and write English.
- Strong attention to detail and ability to identify and resolve documentation discrepancies.
- Excellent written and verbal communication skills.
- Proficiency in using documentation management systems and production software.
- Knowledge of Good Manufacturing Practices (GMP) and relevant regulatory standards in the dietary supplement or pharmaceutical industry.
- Ability to work independently and as part of a team.
