What are the responsibilities and job description for the Associate, QA Documentation 2 position at US Pharma Lab?
Job Description
Role Overview
An Associate, QA Documentation 2, will be responsible for the writing, distribution, collection, storage, and maintenance of our company’s documentation and includes tracking products, materials, status, and location. Involved in the review of vendor and ingredient qualifications as well as the review and issuance of batch records. Participates in audit preparations and other compliance documents.
Areas of Responsibility
- Responsible for collecting samples for verification / validation study batches .
- Tracking receiving of results and daily status.
- Compilation of testing data – Bulk Hold study , Process verification study , Cleaning assessment study
- Responsible for the review and issuance of batch records for verification batches
- Able to prepare material based on specifications.
- Reviews the release of material and products, vendors, and ingredient qualifications.
- Involved in audit preparations as well as the writing, updating, and reviewing of compliance documents.
- Responsible for ensuring products are shipped correctly and what needs to be sent out for testing.
- Scan, file, fax, and organize documents for product specifications.
- Organize product specific documents, compliance documents.
- Acting as a point of contact for retrieval of specific documentation as required
- Other Duties as Assigned
Other Responsibilities Including Safety:
Requirements
Education & Qualification:
- BS/BA degree preferred.
- 3 - 5 years relevant document experience
Certifications, Licenses, Credentials:
- N/A
Skills & Ability
- Demonstrated above average written communication skills in the English language.
- Must be advanced with all MS Office software, must have excellent typing skills.
- The ability to interact with department heads regarding corporate compliance.
- Ability to maintain professional and positive attitude.
- Ability to manage multiple tasks effectively & efficiently.
- Possess a high-level of ethics and integrity.
- Must be able to keep information confidential.
Physical Requirements (lifting, etc.):
- The employee is frequently required to sit (50%), stand, and walk (50%); use of hands to finger, handle or feel writing tools and computer keyboard; may reach with hands and arms and infrequently may lift up to 30lbs.; uses desk telephone/cell phone to talk and hear or converses with other employees.
Work Environment (Office, Warehouse, temperature extremes, etc.):