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Benjamin Tucker
Batch Records Clerk
Summary
Highly accomplished Batch Records Clerk with 5+ years of experience in maintaining accurate and compliant batch production records in the pharmaceutical industry. Proficient in Microsoft Office Suite, FDA 21 CFR Part 11, Good Documentation Practices (GDP), Data Entry and Verification, Document Control, and Quality Assurance (QA). Possess a strong understanding of regulatory requirements and industry best practices. Proven ability to collaborate effectively with production teams, conduct root cause analyses, and implement corrective actions. Committed to ensuring data integrity, accessibility, and compliance, with a passion for continuous improvement and professional development.
Education
Bachelor’s Degree in Science
December 2016
Skills
- Microsoft Office Suite
- FDA 21 CFR Part 11
- Good Documentation Practices (GDP)
- Data Entry and Verification
- Document Control
- Quality Assurance (QA)
Work Experience
Batch Records Clerk
- Utilized electronic batch record systems to manage and archive batch data, ensuring data integrity and accessibility.
- Participated in audits and inspections to demonstrate compliance with batch recordkeeping practices and regulatory guidelines.
- Trained new employees on batch recordkeeping procedures, ensuring consistency and adherence to best practices.
- Developed and implemented record retention policies to ensure the secure storage and retrieval of batch records for regulatory and business purposes.
Batch Records Clerk
- Maintained accurate and complete batch production records, ensuring compliance with regulatory requirements and industry standards.
- Reviewed and verified batch records to ensure all critical data points were captured and accurate, including raw material usage, process parameters, and endproduct specifications.
- Conducted root cause analyses to identify and resolve deviations in batch records, implementing corrective actions to prevent recurrence.
- Collaborated with production teams to ensure batch records accurately reflected actual production conditions and adhered to established procedures.
Accomplishments
- Developed a standardized operating procedure (SOP) for batch record management, significantly streamlining processes and reducing errors.
- Implemented a quality control system to ensure compliance with regulatory requirements, resulting in a 99.9% accuracy rate in batch record validation.
- Spearheaded the transition to an electronic batch record system, resulting in improved efficiency and accessibility.
- Collaborated with production teams to identify and rectify potential batch record discrepancies, preventing errors and ensuring product quality.
- Led the development and implementation of a comprehensive training program for new batch records clerks, ensuring their proficiency and compliance.
Awards
- Received the Batch Records Excellence award for outstanding accuracy and efficiency in managing batch records.
- Recognized for exceptional performance in maintaining compliance with industry best practices and guidelines for batch records.
- Honored for commitment to excellence in batch records management, contributing to the overall quality and safety of products.
- Recognized for proactive problemsolving skills in resolving batch record issues, ensuring timely and accurate production.
Certificates
- Certified Records Manager (CRM)
- Certified Quality Auditor (CQA)
- FDA 21 CFR Part 11 Specialist
- ASQ Certified Quality Inspector
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How To Write Resume For Batch Records Clerk
- Quantify your accomplishments whenever possible to demonstrate the impact of your work.
- Highlight your knowledge of regulatory requirements and industry best practices.
- Showcase your ability to collaborate effectively with cross-functional teams.
- Emphasize your commitment to data integrity and compliance.
- Use industry-specific keywords throughout your resume to increase your visibility to potential employers.
Essential Experience Highlights for a Strong Batch Records Clerk Resume
- Maintained accurate and complete batch production records, ensuring compliance with FDA 21 CFR Part 11 and industry standards.
- Reviewed and verified batch records for accuracy and completeness, including raw material usage, process parameters, and end-product specifications.
- Conducted root cause analyses to identify and resolve deviations in batch records, implementing corrective actions to prevent recurrence.
- Utilized electronic batch record systems to manage and archive batch data, ensuring data integrity and accessibility.
- Collaborated with production teams to ensure batch records accurately reflected actual production conditions and adhered to established procedures.
- Developed and implemented record retention policies to ensure secure storage and retrieval of batch records for regulatory and business purposes.
- Participated in audits and inspections to demonstrate compliance with batch recordkeeping practices and regulatory guidelines.
Frequently Asked Questions (FAQ’s) For Batch Records Clerk
What are the key responsibilities of a Batch Records Clerk?
Key responsibilities include maintaining accurate and complete batch production records, reviewing and verifying batch records, conducting root cause analyses, utilizing electronic batch record systems, collaborating with production teams, and participating in audits and inspections.
What qualifications are required to become a Batch Records Clerk?
Typically, a Bachelor’s Degree in Science or a related field is required, along with proficiency in Microsoft Office Suite, FDA 21 CFR Part 11, Good Documentation Practices (GDP), Data Entry and Verification, Document Control, and Quality Assurance (QA).
What are the career prospects for a Batch Records Clerk?
With experience and additional certifications, Batch Records Clerks can advance to roles such as Quality Assurance Analyst, Regulatory Affairs Specialist, or Production Supervisor.
What are the key skills required for a Batch Records Clerk?
Key skills include attention to detail, accuracy, compliance knowledge, data management, problem-solving, and communication.
What are the typical work hours for a Batch Records Clerk?
Batch Records Clerks typically work regular business hours, but may be required to work overtime or on weekends to meet production deadlines.
What is the average salary for a Batch Records Clerk?
The average salary for a Batch Records Clerk varies depending on experience, location, and company size, but typically ranges from $40,000 to $60,000 per year.