Salary: $ 20.00 per hour
Date Posted: December 31, 2018
Job Type: Temporary to Hire
Job ID: 341950
The Quality Administrator supports the daily execution of Quality System processes. This includes Document and Record Control, Change Control, Personnel Training, Deviations, Non-conformance, CAPA, Management Review, Audit.
General Duties and Responsibilities:
- Administers the Change Control program
- Creates/revises Standard Operating Procedures (SOP) and work instructions.
- Initiates, routes, and implements Change Requests as assigned.
- Distributes new and updated SOPs, Forms, WIDs
- Collects superseded and obsoleted SOPs, Forms, WIDs.
- Coordinates periodic review of SOPs.
- Maintains, updates, and archives GMP records including batch records, purchase orders, complaint records, training records.
- Coordinates archival, retrieval, and destruction of GMP records from off-site storage facility.
- Supports backroom activities on regulatory and 3rd party inspections
- Assists with the completion and approval of Deviations and CAPAs.
- Assists recall activities as assigned.
- Trains and provides guidance on Quality System processes and related activities
- Collects and compiles data from various Quality System databases and presents to Operations Management team.
- Establishes a good quality of work
- Participates in team meetings and strategy sessions
- Participates in continuous improvement initiatives
- Minimum of 1 year in pharmaceutical operations required.
- High School Diploma required. Bachelor's degree preferred, health sciences preferred.
- Internal auditing experience a plus.
- Working knowledge of FDA GMP regulations and quality system regulations
- Knowledge of manufacturing processes.
- Good communication skills at all levels, both written and verbal; both individually and in a group setting.
- Strong skills in analytical thinking and problem solving.
- Ability to perform multiple tasks and ability to effectively manage conflict.
- Ability to work in teams to obtain results.
- Must have working knowledge of basic PC software: Excel, MS Word, PowerPoint, etc.