Highlights
Key Responsbilities: Coordinate and perform review and approval of completed batch records, raw material records, validations, stability records, and other quality documents to ensure compliance with applicable procedures, test specifications and methods. Perform document record review and approval of batch records, equipment qualifications, calibration records, analytical methods, method validations, stability protocols, and other quality documents for completeness and accuracy.
Numbers & Facts
| Location | Round Rock, TX |
| Industry | Staffing/Employment Agencies |
| Company Size | 100 to 499 employees |
| Year Founded | 1998 |
Description
Title: Quality Assurance Specialist
12 month contract, temp to perm potential (dependent on business needs and performance)
Mon-Fri 8am-5pm CST
100% on-site
Pay Range: ***-***/hr.
4 Total (3 Batch Record Review, 1 Split with Compliance)
Description:
Key Responsbilities:
Coordinate and perform review and approval of completed batch records, raw material records, validations, stability records, and other quality documents to ensure compliance with applicable procedures, test specifications and methods
Perform document record review and approval of batch records, equipment qualifications, calibration records, analytical methods, method validations, stability protocols, and other quality documents for completeness and accuracy
Generating and review Certificate of Analysis (CoA) for catalog and custom projects
Assist in preparation and hosting external audits including customer, ISO, and DEA audits
Generate quarterly metrics summarizing documentation review and production activities
Perform review and approval of Standard Operating Procedures to ensure compliance with regulatory and company quality requirements
Regularly communicate with the QA management any problems and concerns that may delay or lead to the failure of the completion of projects, qualifications, validations, or other quality documents
Assist with internal audits as needed to maintain audit schedule
Support rollout of local and corporate initiatives
Minimum Qualifications:
Bachelor's Degree in Chemistry, Biology, or other Life Science Discipline
5+ years of experience in an ISO environment
Preferred Qualifications:
Working knowledge of quality system requirements of the pharmaceutical and/or clinical industries
Prior work experience in an ISO, or similarly regulated environment
Knowledge of ISO 9001, ISO 17025, ISO 17034 and ISO 14001
Strong technical knowledge base and the ability to comprehend and communicate basic technical concepts
Ability to communicate effectively with all levels within the organization and with outside contacts
Self-motivated with the ability to work independently
Ability to critically review documents for discrepancies with written procedures and requirements
Knowledge with Root Cause Analysis and experience with eQMS system Veeva or similar
12 month contract, temp to perm potential (dependent on business needs and performance)
Mon-Fri 8am-5pm CST
100% on-site
Pay Range: ***-***/hr.
4 Total (3 Batch Record Review, 1 Split with Compliance)
Description:
Key Responsbilities:
Coordinate and perform review and approval of completed batch records, raw material records, validations, stability records, and other quality documents to ensure compliance with applicable procedures, test specifications and methods
Perform document record review and approval of batch records, equipment qualifications, calibration records, analytical methods, method validations, stability protocols, and other quality documents for completeness and accuracy
Generating and review Certificate of Analysis (CoA) for catalog and custom projects
Assist in preparation and hosting external audits including customer, ISO, and DEA audits
Generate quarterly metrics summarizing documentation review and production activities
Perform review and approval of Standard Operating Procedures to ensure compliance with regulatory and company quality requirements
Regularly communicate with the QA management any problems and concerns that may delay or lead to the failure of the completion of projects, qualifications, validations, or other quality documents
Assist with internal audits as needed to maintain audit schedule
Support rollout of local and corporate initiatives
Minimum Qualifications:
Bachelor's Degree in Chemistry, Biology, or other Life Science Discipline
5+ years of experience in an ISO environment
Preferred Qualifications:
Working knowledge of quality system requirements of the pharmaceutical and/or clinical industries
Prior work experience in an ISO, or similarly regulated environment
Knowledge of ISO 9001, ISO 17025, ISO 17034 and ISO 14001
Strong technical knowledge base and the ability to comprehend and communicate basic technical concepts
Ability to communicate effectively with all levels within the organization and with outside contacts
Self-motivated with the ability to work independently
Ability to critically review documents for discrepancies with written procedures and requirements
Knowledge with Root Cause Analysis and experience with eQMS system Veeva or similar
About Company
Atlas Data Systems provides information technology services, business solutions, and clinical/scientific consulting to a broad range of Fortune 1000 companies. As one of the fastest growing women-owned businesses, our client list comprises top companies in the pharmaceutical, chemical, financial services, telecommunications, technology, insurance, manufacturing and software industries.
Our expertise lies in delivering the right mix of solutions and services that will help our clients' business operations proactively meet their competition head on, and be agile enough to react to ever-changing economic conditions. Atlas' adaptability allows clients to choose the best fit engagement strategy: Managed Communities, Project Solutions, or Flexible Workforce Solutions. By concentrating on peripheral business objectives and delivering with precision, Atlas enables its clients to focus on the core competencies that align with their company's vision.