Batch Record Reviewer


Job ID 19-00054

Industry Pharma

Job Type Permanent

Location Dayton, NJ

Description

Description
- Review Batch Record, Test Results, Certificate of Analysis and Release of Commercial products
- Manage completion of required batch record corrections by interacting with responsible parties and counseling personnel on proper cGMP documentation practices
- Manage the batch disposition process by ensuring that all required documents are accurately and properly completed
- Maintain Batch Record Review and Release spreadsheet
- Review/ entering information different systems (i.e. APR, LIMS, ERP)
- Handle various requests from departments for developmental or investigative reasons
- Work with IPQA Supervisor and or other departments to assist in any matter when required
- Initiation/ Completion of Change Control and or Deviations
- Write and revise SOP as needed
- Compiling data for metric trending



Qualifications

Qualifications:
- Associate Degree or a minimum of 3 years of professional experience in pharmaceutical quality assurance environment with understanding of cGMPs and record documentation requirements
- Read, write and speak English

Required:
- Minimum 3- 5 years of batch record review experience and product disposition
- Must be proficient with pharmaceutical drug manufacturing processes , cGMP and other regulatory requirements
- Must be a Team player and effectively communicate both orally and in writing with QA Supervisor, IPQA, Quality Control, Production and Supply Chain to meet finished product release goals
- Strong organizational and time management skills
- Be able to work long hours to support Production schedule and monthly Marketing goals

Physical requirement:
- Must be able to sit for long periods of the shift