What are the responsibilities and job description for the Batch Record Coordinator position at NutraStar?
Job Purpose:
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.
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.
Expectations
● Act with integrity and ask for assistance and clarification when questions/issues arise.
● Demonstrate mutual respect for all employees.
● Ability to thrive in a “Team Oriented Environment.”
● Ability to work independently if required.
● Lead the Floor to have good practice over Batch Records.
● Provide guidance and training to production personnel on proper documentation practices and adherence to batch record protocols to support continuous compliance.
Qualifications
● 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.
● Promote a safe work environment: ensure all safety protocols are followed, identify, and address potential safety hazards and investigate and report any accidents or near misses immediately to the Supervisor or EH&S Manager.
● Follow OSHA Manufacturing Safety Awareness and precautions.
● Comprehends and adheres to all pertinent Health and Safety Regulations, Policies and Procedures.
● Ensure all GMP guidelines are adhered to, wear PPE, follow biohazard safety standards.
● Lifting, pushing, and pulling products.
● Ability to handle 20-25 lbs. on a frequent basis from floor to chest high.
● Standing for extended periods of time.
● Work environment may be exposed to powders, chemicals, and allergens (peanuts, tree nuts, milk, dairy, eggs, wheat, gluten, soy, fish and shellfish.)
The following Regulations must be adhered to:
● 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)
