QA Batch Record Review I
About The Position
This position is responsible for providing the Quality Assurance review associated with the manufacture of safe, pure, effective, and sterile pharmaceuticals in accordance with company Standard Operating Procedures (SOPs), policies and current Good Manufacturing Procedures. The Batch Record reviewer ensures all documentation, processes and products meet specifications and that Batch Records are completed in accordance with GMP requirements. This position requires effective collaboration with other departments on production issues/situations, product dispositions and investigations. The Batch Record reviewer works under the direct supervision of the QA Supervisor. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Requirements
- High School Diploma or GED equivalent required.
- Minimum 3 years’ experience preferred in QA in a cGMP manufacturing environment.
- Skills in Microsoft Word and Excel are required.
- Excellent organizational, interpersonal and communication skills (written and oral) required.
- Strong attention to detail and adherence to Standard Operating Procedures (SOPs).
- Ability to take feedback constructively and function in a team-oriented work environment.
- Ability to work overtime as needed.
Nice To Haves
- Associates or Degree, preferred.
- Experience in QA, Compliance, Auditing in a cGMP manufacturing environment is preferred.
- Demonstrated success in managing multiple activities at the same time and producing outstanding results.
Responsibilities
- Execute timely reviews all batch documentation for accuracy and completeness according to cGMP’s.
- Execute batch record review and review of supporting systems including Veeva Vault and Trackwise.
- Adheres to internal and external guidelines, specifications and regulatory requirements while reviewing batch documentation.
- Ensures all work in performed and documented in accordance with existing company policies and procedures, as well as cGMP and health and safety requirements.
- Work with area personnel to resolve errors and/or discrepancies.
- Assures all errors and corrections are resolved according to SOP requirements.
- Enter data into applicable spreadsheets/databases.
- Update metric reporting as needed.
- Submit error free batch records to release for product shipments.
- Execute batch record review of Media Fills and Research and Development (R&D) batches.
- Review and approve preliminary batch records after batch record assembly.
- Review logbooks for accuracy after creation.
- At any time may be required to perform the job responsibilities for the Documentation Specialist.
- Perform any other tasks/duties as assigned by management.
Benefits
- American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
501-1,000 employees
