Quality Control Data Reviewer

Job Title: Quality Control Data Reviewer
Location: Philadelphia, PA
Type: Contract
Compensation: $40-45.77/hr
Hours: 40.0 hours per week

Responsibilities

• Review and approve GMP data, including paper and electronic data
• Review audit trails and instrument logbooks
• Hire, train, and supervise data reviewers
• Develop and maintain data integrity program
• Author and review SOPs, manage non-conformance events as needed
• Develop and maintain department metrics on turnaround and right first time
• Support QC during audits and regulatory inspections
• Assist on instrument assessment and sample management activities

Requirements

• BS or MS degree in biological, chemical sciences, or related discipline
• 5+ years of related experience for BS, 2+ years for MS, 1+ years for PhD in the Pharmaceutical/Biotech industry working in a GMP/regulated environment
• Strong scientific knowledge and demonstrated analytical background
• Familiarity with assays such as SDS-PAGE, Western Blot, SEC, CE-SDS, cell-based assay, qPCR, ddPCR, ELISAs, DLS, and compendial assays
• Excellent understanding of data integrity principles
• Proven experience with analytical instruments and audit trail review preferred
• Experience in lab investigation and deviation management preferred
• Excellent communication skills
• Strong interpersonal, organizational, and time management skills
• Ability to multitask and work independently or in a team with minimal supervision
• Proven analytical aptitude and critical thinking skills

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.