Batch Record Reviewer I

About the role

The Batch Record Reviewer plays a critical role in ensuring company compliance with regulatory requirements and customer satisfaction through meticulous review of documentation related to contract packaging.

Responsibilities

• Review documentation related to primary, secondary, and clinical packaging after completion of reconciliation.
• Perform critical review and logging of all documentation for errors, omissions, overwrites, and compliance with cGMPs, customer specifications, and internal SOPs.
• Follow up on customer inquiries specific to documentation related to packaging, testing, and release of work-in-process or finished product.
• Release work-in-process or finished product for distribution.
• Review and maintain QAD Item Master Maintenance and Router Maintenance.
• Log and maintain packaging process samples, and coordinate shipment of samples to customers.
• Maintain and file documentation related to packaging in appropriate status locations.
• Enter lot-specific information into the Quality Dashboard (Access Database).
• Participate in internal, customer, and regulatory audits as required by senior management.
• Perform other duties as assigned.

Requirements

• High school diploma or equivalent (required).
• One to two years of related pharmaceutical experience and/or training, or equivalent combination of education and experience (preferred).
• Experience in the pharmaceutical or related industry (desired).
• General knowledge of FDA regulations related to cGMPs (required).
• General knowledge of cGDPs (required).
• General knowledge of quality control/assurance (required).
• General knowledge of DEA regulations (preferred).
• Excellent attention to detail, particularly in documentation review and compliance.
• Strong written and oral communication skills.
• Good organizational and planning skills.
• Excellent interpersonal skills.
• Must be over 18 years of age and pass a pre-employment drug test and background check.

Skills

• Proficiency in Microsoft Office Suite, Adobe Acrobat, and QAD.
• Experience with Pilgrim SmartSolve system (desired).
• Ability to apply moderately complex mathematical operations, including statistical sampling plans and calculations involving time, percentages, and decimals.
• Basic math skills (addition, subtraction, multiplication, and division).
• Strong reasoning and problem-solving abilities.
• Ability to respond to inquiries from customers, peers, and superiors.
• Ability to present information effectively to internal and external stakeholders.

Physical Demands

• Regularly required to use hands, speak, and listen.
• Frequently required to sit.
• Occasionally required to stand, walk, and reach with hands and arms.
• Must occasionally lift and/or move up to 20 pounds.
• Requires close vision, distance vision, and ability to adjust focus.

Work Environment

The role involves working in an environment typical for office and documentation review settings, with reasonable accommodations available for individuals with disabilities.