Welcome to AbbVie, a global biopharmaceutical company dedicated to discovering and delivering innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We are currently seeking a meticulous and detail-oriented Batch Record Reviewer to join our team.In this role, you will play a critical part in ensuring the quality and compliance of our products by reviewing and approving batch records in accordance with regulatory standards. You will have the opportunity to work with a team of passionate individuals who are committed to making a difference in patients' lives.To excel in this position, we are looking for someone with a strong background in Quality Assurance, excellent attention to detail, and an understanding of cGMP regulations. If you are driven, self-motivated, and have a passion for upholding high-quality standards, we encourage you to apply for this exciting opportunity.
Review and approve batch records for compliance with regulatory standards and company policies.
Ensure accuracy and completeness of batch records, including documentation of all manufacturing and testing activities.
Collaborate with cross-functional teams to resolve any discrepancies or issues identified during batch record review.
Maintain a thorough understanding of cGMP regulations and company procedures to ensure compliance.
Communicate any changes or updates to batch records to relevant stakeholders.
Participate in investigations related to batch record discrepancies or non-conformances.
Identify areas for improvement in batch record processes and suggest solutions to enhance efficiency and compliance.
Keep accurate and organized records of batch record review activities and findings.
Provide support during regulatory inspections and audits by presenting batch record documentation and responding to inquiries.
Train and mentor other team members on batch record review processes and procedures.
Stay updated on industry trends and advancements in batch record review and quality assurance practices.
Collaborate with the Quality Assurance team to develop and implement quality improvement initiatives.
Adhere to all company safety and compliance protocols and report any potential risks or hazards.
Uphold AbbVie's mission and values by promoting a culture of integrity, teamwork, and excellence.
AbbVie is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Location: Chicago, IL
Posted: Oct. 13, 2024, 3:46 a.m.
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