About the job
Candidate will work as a Quality Batch Release Assistant to perform a timely and efficient cGMP and quality review of batch record documentation to ensure prompt batch disposition and release. This person will serve as reviewer and/or approver for required documentation in a pharmaceutical manufacturing setting, ensuring compliance to FDA regulations and plant procedures. The successful candidate will be able to manage multiple tasks and adjust priorities based on supply needs. This position requires the ability to positively interact with multiple functional areas quickly and effectively resolve batch record documentation related issues, ensuring schedules are maintained and material is readily available.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
•Reviews all batch documentation for accuracy and completeness according to cGMP’s to ensure timely release of batches
- Execute batch record review and review of supporting systems
- Adheres to internal/external guidelines, specifications and regulatory requirements while reviewing batch documentation
- Ensure all cGMP’s, Work Procedures and SOP’s are followed
- Identify exceptions and report exceptions to production
- Ensure deviations are initiated or completed for any batch record review related events, communicate deviations to appropriate department for investigation
- Effectively resolve documentation discrepancies and issues with manufacturing operations personnel in a timely manner to allow for material release
- Addresses deficiencies and ensures timely completion of all follow-up actions for resolution to all batch review issues according to GMP standards
- Responsible for final batch disposition based on review of all associated documentation
- Assist in resolving quality problems/concerns related to batch review
- Work proactively on a daily basis to ensure schedules are maintained and material is readily available
- Build quality into all aspect of the material release process by maintaining compliance to all quality requirements
Note: The above statements describe the general nature and level of the work being performed and are not an exhaustive list of all responsibilities of an employee in this job. Job duties can change at any time as directed by management. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of the employer.
Set yourself apart
EDUCATION and/or EXPERIENCE
- High School Diploma or Equivalent
- Excellent verbal and written communication skills
- Proficient in Microsoft Office
- Proficient in Microsoft Outlook
- Experience in manufacturing is preferred
- Knowledge of good documentation practices is preferred
What’s on offer?
AnazaoHealth offers competitive salaries and a comprehensive benefit package to include 401(k) with company match, health insurance coverage for you and your dependents, paid holidays, PTO, and Volunteer Paid Time Off.