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.
This position will help ensure compliance with SOPs, GMP documentation and 21 CFR Part 111 and 117.
This position Reports to the Quality Assurance Director and dotted line to VP of Quality Assurance.
Areas of Responsibility
- Prepare and manage customer product specification documents, COAs, SDS certificates and vendor qualification documents.
- Review product labels and supplement facts.
- Prepare and / or approves technical questionnaires , Supplier Qualification, Food Safety Plan, and other quality related documents.
- Prepare /Review/approve changes in accordance with SOPs.
- Oversee the revision of documents for proper grammar, spelling, punctuation, presentation, etc., and to improve clarity, syntax, logic, flow, organization, etc.
- Coordinate releases of finished products.
- Create documentation that meets the regulatory requirements before distributing it to USPL users .
- 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
- 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
- Plays an active role in the Company’s quality management team. Other Duties as Assigned
Requirements
Education & Qualification:
- Bachelor’s or master’s degree in science preferred
- 2 - 4 years’ technical experience OR a combination of education and experience equivalent to the above requirements.
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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 a professional and positive attitude
- Ability to manage multiple tasks effectively & efficiently
- Possess 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.):
