Catalent

Batch Record Reviewer

Catalent

Baltimore, MD, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

At Catalent, we are looking for a motivated and experienced Batch Record Reviewer to join our team. As a Batch Record Reviewer, you will be responsible for reviewing and approving batch production and control records for compliance with cGMPs and other regulatory requirements.We are looking for an individual with a strong attention to detail, excellent communication skills, and the ability to work well in a team environment. The successful candidate will have experience in the pharmaceutical industry, including cGMPs and experience in batch record review. A Bachelor’s degree in a related field is preferred.This is an excellent opportunity to join a global leader in the pharmaceutical industry and to work with a talented and passionate team. We offer a comprehensive benefits package and competitive salary.

Responsibilities:

  1. Review and approve batch production and control records for compliance with cGMPs and other regulatory requirements.
  2. Follow all company policies and procedures related to batch record review.
  3. Maintain accurate and organized documentation of batch record review.
  4. Maintain a thorough understanding of cGMPs and industry regulations related to batch record review.
  5. Communicate effectively with team members to ensure a smooth and efficient review process.
  6. Provide guidance and direction to team members when necessary.
  7. Utilize problem-solving skills to address any issues that arise.
  8. Identify areas for improvement and provide recommendations for process optimization.
  9. Work cooperatively with other departments to ensure compliance with regulations and company policies.
  10. Keep up-to-date with industry trends and developments.
Where is this job?
This job is located at Baltimore, MD, USA
Job Qualifications
  • Ability To Work In A Fast-Paced Environment

  • Good Knowledge Of Gmp

  • Good Knowledge Of Computer Systems

  • Good Analytical Skills

  • Good Understanding Of Batch Records

  • Ability To Identify Discrepancies In Records

  • Ability To Work Independently And Within A Team

  • High Degree Of Accuracy And Attention To Detail

Required Skills
  • Documentation

  • Quality Assurance

  • Data Entry

  • Communication

  • Attention to detail

  • Problem Solving

  • Auditing

  • Analytical Thinking

  • Technical Writing

  • Risk assessment

  • Process optimization

  • Regulatory compliance

  • Process Control

  • Recordkeeping

  • Batch Tracking

Soft Skills
  • Communication

  • Conflict Resolution

  • Leadership

  • Time management

  • Interpersonal Skills

  • creativity

  • collaboration

  • Adaptability

  • Problem-Solving

  • Decision-making

Compensation

According to JobzMall, the average salary range for a Batch Record Reviewer in Baltimore, MD, USA is $38,914 - $67,146 per year. The salary range is dependent upon experience, job responsibility, and other factors.

Additional Information
Catalent 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.
Required LanguagesEnglish
Job PostedJuly 6th, 2023
Apply BeforeMay 22nd, 2025
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About Catalent

Catalent, Inc. is a multinational corporation headquartered in Somerset, New Jersey. It is a global provider of delivery technologies, development, drug manufacturing, biologics, gene therapies and consumer health products. It employs more than 14,000 people, including approximately 2,400 scientists and technicians.

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