As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!
location: Holly Springs, North Carolina
job type: Contract
salary: $60.00 - 71.60 per hour
work hours: 9 to 5
education: Masters
responsibilities:
- Extensive experience designing/writing protocols/reports for Method Validations, Verifications, Transfers, Material Qualifications, and Stability studies.
- Core Analytical Competencies must include, but not limited to, HPLC/UPLC, HPIC, SEC (UV, CAD, ELSD, Fluorescence, Conductivity)K-F, TOC, ELISA, cell based assays, peptide mapping, glycan, aggregate and excipient analysis, and sample preparation techniques.
- Create strong technically sound Standard Operating Procedures (SOPs), Operation and Maintenance (O&M) Procedures, Equipment Data Integrity Assessments, etc. required to support QC Laboratory Startup
- Process document changes within the electronic Quality Management System (eQMS) while ensuring good documentation practices (GDP)
- Manage document lifecycle updates to support QC Laboratory Readiness metric reporting
- Author Analytical Equipment Qualification Protocols (Performance Qualification Protocols) and Compendial Verifications to support ANC QC Laboratory Readiness as necessary
- Provide validation and change management support for Laboratory Equipment/Method Readiness.
- Lead QC Quality Risk Assessments for Sample Chain of Custody and Analytical Testing
- Provide incident management support associated with nonconformances
- Identify technical/operational gaps and propose solutions.
qualifications:
- Doctorate Degree or Master Degree and 3 years of clinical experience or Bachelor Degree and 5 years of clinical experience or Associate degree and 10 years of clinical experience or high school diploma/GED and 12 years of clinical experience
skills: Quality control, SOP, GMP (Good Manufacturing Practice)
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.
