What are the responsibilities and job description for the QA Document Associate I-III position at AmbioPharm, Inc.?
We are hiring for a QA Documentation Associate I-III opening. This is 1st shift from 8am-4:30pm. Apply Now to learn more!
Primary Responsibilities:
- Assist in the development and maintenance of document filing systems for storage of controlled documents, including but not limited to change controls, deviations, CAPAs, BPRs, analytical data, validations, laboratory notebooks, training files, and logbooks.
- Maintain history and current files for SOPs, Certificate of Analysis, Specifications, test method, datasheet, master BPRs and other documentation as necessary.
- Fulfill internal and external (FDA inspections and customer audits) requests for controlled documents. Maintain the logbook for document check-in/outs.
- Issuance, scanning, and filing of data record sheets.
- Issuance of ALN (Action Limit Notification), Risk Assessment, and Paper Change Controls/Change Controls
- Infocard creation in MasterControl
- Maintenance of documents in MasterControl
- Issuance, scanning, and filing of stability and validation documents
- Daily quality metrics
- Issuance of weekly sheets
- Scanning and filing of equipment records
- Filing of raw material stock cards
- Issuance, scanning, and filing of crude and intermediates
- Issuance, scanning, and filing of Cleaning verifications
- Issuance, scanning, and filing of Analytical data
- Perform Quality walkthroughs of Areas of the facility
- Issuance, scanning and filing of Master Batch Records and Production Records
- Other responsibilities as assigned.
Qualifications:
- Ability to effectively communicate with all levels of the organization.
- Knowledge of GMP and safety regulations
- Ability to facilitate problem identification and assess possible solutions with minimal support.
- Good planning and organizing skills.
- General understanding of World Class Manufacturing and GMP expectations
- Must exhibit the flexibility needed to respond to frequent changes in production requirements and/or systems and equipment failures.
- Awareness of OSHA regulations, GMP, facility safety regulations
Requirements based on the Level:
Level I
- College Degree Preferred
- High School Diploma or GED with 1-3 years’ experience
Level II
- College Degree Preferred
- High School Diploma or GED with 5-8 years’ experience
Level III
- College Degree Preferred
- High School Diploma or GED with 10 years’ experience
ADA-These Requirements are a Condition of Employment:
- Must be able to push, pull, squat, stand and walk through-out the day.
- Must be able to lift up to 40lbs.
- Must be able to wear safety shoes & glasses through-out the day if in designated areas (provided by the company)