QA Specialist – Batch Records Reviewer (IPQA)


Job ID 18-00038

Industry Pharma

Job Type Permanent

Location Dayton, NJ

Description

REPORTS TO: QA Manager DEPT: Quality Assurance
JOB SUMMARY
- Must complete all proper training forms for the applicable responsibilities listed below and contained within the position's specific syllabus.
- Must be a Team player able to effectively communicate with QA Supervisor, IPQA, Quality Control, Production and Supply Chain to meet finished product release goals.
- Responsible for all Batch Record review and release duties at Client
- Have 2-3 years experience reviewing production and controlled documentation as used in the manufacture and packaging of pharmaceuticals.
- Be able to work long hours (overtime and weekends) as needed per marketing requirements.
- Maintain Record Review and Release Spreadsheet
- Enter batch records and C of A's entries in APR.
- Release and approved batches in ERP.
- Approve C of A's in LIMS.
 

REPORTING RELATIONSHIPS.
This position reports directly to the QA Manager (HOD of Quality if so designated
 

DUTIES & ESSENTIAL JOB FUNCTIONS
PERCENT OF TIME - FREQUENCY - ESSSENTIAL DUTIES

70% -  DAILY - Keeping up with Batch Record Review and Release of Commercial products
5% - DAILY - Manage completion of required batch record corrections by interacting with responsible parties
5% - Weekly - Counseling personnel on proper cGMP documentation practices
5% - Daily - Maintain Batch record Review and Release spreadsheet.
20% - Daily - Enter Batch records and C of A's entries in APR.
5% - Weekly - Handle various requests from departments for developmental or investigative reasons
5% - Weekly - Work with IPQA Supervisor to assist in any matter when required.
 

OTHER FUNCTIONS AND RESPONSIBILITIES
- Other responsibilities as assigned by the Department Head



Qualifications

QUALIFICATIONS
- Minimum of 3 years experience
 

REQUIRED
- Minimal 3 years experience in batch record review and product disposition
- Capable of effectively communicating both orally and in writing
- Possess superior organizational and time management skills
- Mental ability to deal with issues and offer resolutions to the same
- Be able to work long hours to support Production schedule and monthly Marketing Goals
 

PREFERRED
- Three years experience with pharmaceutical manufacturing/packaging of generic solid and semi-solid oral dosage forms.
 

ANY REQUIRED LICENSES/CERTIFICATIONS
Not Applicable
 

PHYSICAL REQUIREMENTS/WORK ENVIRONMENT
- Must be able to sit for long periods of the shift.
- Must practice good personal hygiene