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location: Telecommute
job type: Contract
salary: $45.00 - 58.38 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
Provides GDP Quality Assurance support to Lead, Quality Assurance, US GDP by supporting the following activities:
- Annual supplier qualification
- Support 3PL activities
- Work Instruction Review/Approval
- Nonconformance reports/Incident Reports Review/Approval
- Quality discrepancy reports (Nonconformance Approval)
- GDP QA input for Business Review Management
- Upstream supply chain activities (product shipped from plants/suppliers to company 3PL)
- Temperature Excursion Management, including but not limited to approval of temperature deviations for shipments sent to 3PL and update of the temperature excursion handling process
- Product Damage Management, including but not limited to approval of deviations for shipments sent to 3PL and update of the product damage handling process
- Document Management and archival of the GDP QA documents in Veeva/eQMS
- Supports with any GDP related activities
qualifications:
Required:
- BA / BS in a science field, with minimum 5 years of pharmaceutical industry experience, minimum 3 years of QA experience.
- Knowledge of GDP and other relevant regulations, as required, with a broad knowledge of quality principles and industry trends.
- Effective written and oral communication and interpersonal skills, facilitation, and influencing skills with an ability to effectively work across the company groups and with external stakeholders.
- Must be a self-starter, proactive and have the ability to manage department resources to achieve the desired outputs on a daily basis.
- Experience using GxP Documentation systems (Such as Trackwise (Digital), Veeva, SAP systems).
- Direct experience in Quality Assurance function, GDP preferred
- Working knowledge of global industry standards and regulatory requirements (e.g., US, EU and Japan).
- Proficient with MS Excel, WORD, PowerPoint.
skills: Quality Assurance, MS-WORD, MS-EXCEL, MS-Powerpoint
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
