Description

Location: Mason, OH (Remote)

TECHNICAL SKILLS

Must Have

• Attention to Detail
• Batch Record Review
• Good Documentation Practice

Nice To Have

• Ability to balance time-based priorities
• Advanced organizational and time management skill
• Has strong communication skills

Position Overview:

• The Batch Record Release Coordinator is a critical role within our Quality Assurance department, responsible for the thorough review and approval of executed batch records from our external business partners to ensure compliance with internal standard operating procedures (SOPs), Good Manufacturing Practices (GMP), and regulatory requirements.
• The ideal candidate will possess a strong understanding of Good Documentation Practices (GDP) and demonstrate exceptional attention to detail.
• This role requires the ability to manage multiple priorities and meet strict deadlines in a fast-paced environment.

Key Responsibilities:

Batch Record Review:

• Conduct comprehensive reviews of batch records for accuracy, completeness, and compliance with GMP and GDP standards.
• Ensure all required documentation is present, including but not limited to, production records, equipment cleaning and sanitization logs, and quality control results.
• Identify and escalate any discrepancies or deviations in batch records, facilitating timely resolutions.

Documentation Practices:

• Uphold and promote Good Documentation Practices throughout the organization.
• Identify Good Documentation Practices improvement areas via batch record review and communicate these to the External Business Partners as appropriate.

Collaboration and Communication:

• Work closely with cross-functional teams, including Production, Quality Control, and Regulatory Affairs, to facilitate efficient batch record review processes.
• Communicate effectively with team members and management regarding batch record issues, trends, and compliance challenges.

Prioritization and Time Management:

• Manage and prioritize multiple batch record reviews simultaneously, ensuring timely release of products in accordance with production schedules across multiple Contract Manufacturing sites and product forms (cosmetics, medical devices, and drugs).
• Adapt to changing priorities and deadlines while maintaining a high level of accuracy and thoroughness in reviews.