Quality Assurance Specialist - Florida, United States - EPM Scientific

Description

Quality Specialist, Batch Release

Location: Florida

Work situation: On-site

As a Quality Specialist focused on product release and batch record management, you will play a crucial role in ensuring that our products meet regulatory requirements and quality standards before they are released to the market. You will be responsible for overseeing batch record review, batch release, and lot release activities to ensure compliance with regulatory requirements and internal quality procedures.

Key Responsibilities:

• Batch Record Review: Conduct thorough review of batch records to ensure accuracy, completeness, and compliance with regulatory requirements and company procedures.
• Batch Release: Collaborate with cross-functional teams including Manufacturing, Quality Control, and Regulatory Affairs to review and approve batch documentation for product release.
• Lot Release: Manage the lot release process, including reviewing analytical data, documentation, and conducting final product inspections to ensure compliance with specifications and standards.
• Quality Compliance: Ensure compliance with applicable regulations such as FDA, cGMP, and company quality standards throughout the product release process.
• Investigation and Resolution: Investigate and resolve any discrepancies or deviations identified during batch record review or product release activities, collaborating with relevant stakeholders to implement corrective and preventive actions as necessary.
• Continuous Improvement: Identify opportunities for process improvements in batch record management and product release activities to enhance efficiency and compliance.
• Documentation and Reporting: Maintain accurate and up-to-date documentation related to batch record review, batch release, and lot release activities. Generate reports and metrics to track key quality performance indicators.
• Training and Support: Provide training and support to manufacturing and quality control personnel on batch record documentation practices and quality requirements.

Qualifications:

• Bachelor's degree in a scientific or related field.
• Minimum of 2 years of experience in quality assurance or quality control roles within the pharmaceutical, biotechnology, or medical device industry.
• Strong knowledge of FDA regulations, cGMP requirements, and industry best practices related to product release and batch record management.
• Experience with batch record review, batch release, and lot release activities in a regulated manufacturing environment.
• Strong problem-solving skills and ability to effectively collaborate with cross-functional teams to resolve issues..
• Ability to work independently and prioritize tasks in a fast-paced environment.

Benefits:

• 401k match
• Competitive salary
• Health, dental and vision insurance