Records Review Associate 1st Shift
Bridgewater, MA, US
Scientific
High School or equivalent
Full Time, Direct Hire
Entry Level
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
Bridgewater, MA, US
Entry Level
Full Time, Direct Hire
Biotechnology/Pharmaceuticals
On-site
Scientific
High School or equivalent
First Shift (Day)
Job details
Records Review Associate
Monday – Friday 7:00 a.m. – 3:00 p.m.
Short-Term Project until November or December
Responsible for ensuring company products comply with internal and external specifications by performing a variety of routine and non-routine inspections and evaluations. This includes activities related to Inspection and Testing, Batch Release and Records Management.
- Batch Release and Records Management
- Audits batch records to ensure compliance with policies, procedures and regulations.
- Ensures batch records are complete and accurate, with all NC’s dispositioned prior to release.
- Identifies, records and reports on batch non- conformances and product holds.
- Stores and maintains batch files either physically or electronically based on established guidelines.
General Responsibilities:
- Applies principles of Good Documentation Practices.
- Executes assigned NR actions within the applicable software application.
- Provides metrics and updates on executions.
- Maintains training records up-to-date.
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