QA Batch Release Assistant (1st Shift)

About the role

The Batch Release Assistant will perform a timely and efficient cGMP and quality review of batch record documentation to ensure prompt batch disposition and release. This person will serve as reviewer and/or approver for required documentation in a pharmaceutical manufacturing setting, ensuring compliance to FDA regulations and plant procedures.

Responsibilities

• Reviews all batch documentation for accuracy and completeness according to cGMP’s to ensure timely release of batches.
• Execute batch record review and review of supporting systems, to include LUMAC review.
• Adheres to internal/external guidelines, specifications and regulatory requirements while reviewing batch documentation.
• Ensures all GMP’s, Work Procedures and SOP’s are followed.
• Identify exceptions and report exceptions to production.
• Ensures deviations are initiated for any batch record review related events
• Find/communicate deviations to appropriate department for investigation.
• Effectively resolve documentation discrepancies and issues with manufacturing operations personnel in a timely manner to allow for material release.
• Addresses deficiencies and ensures timely completion of all follow-up actions for resolution to all batch review issues according to GMP standards.
• Responsible for final batch disposition based on review of all associated documentation.
• Aid in resolving quality problems/concerns related to batch review.
• Work proactively on a daily basis to ensure schedules are maintained and material is readily available.
• Build quality into all aspect of the material release process by maintaining compliance to all quality requirements.

Requirements

• High School Diploma or Equivalent
• Excellent verbal and written communication skills
• Proficient in Microsoft Office
• Proficient in Microsoft Outlook
• College credits in biology, chemistry, or science related courses is preferred
• Experience in manufacturing is preferred
• Knowledge of good documentation practices is preferred

Qualifications

• High School Diploma or Equivalent
• Excellent verbal and written communication skills
• Proficient in Microsoft Office
• Proficient in Microsoft Outlook
• College credits in biology, chemistry, or science related courses is preferred
• Experience in manufacturing is preferred
• Knowledge of good documentation practices is preferred

Skills

• Strong attention to detail
• Ability to manage multiple tasks and adjust priorities
• Good problem-solving skills
• Effective communication skills

Benefits

• Competitive salary
• Comprehensive benefits
• Performance package
• Opportunity to be part of an international leader in an expanding industry