Title: QA Specialist
Location: Monmouth Junction, NJ
Schedule: Monday Friday (8am-5pm)
Type: Contract (opportunity to go perm)
Start date: ASAP
This position supports the QA function by ensuring manufacturing quality controls and procedures are followed in accordance to Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) standards and batch record specifications. The incumbent supports and assesses operational needs and activities in order to successfully achieve quality goals and metrics across multiple quality functions including, but not limited to: documentation, compliance, operations, etc.
She/he may assist in the maintenance and tracking of all Quality related documentation including, but not limited to: Investigations, CAPAs, Planned Deviations, Change Controls, etc.
Maintains all investigation and CAPA related documentation, as assigned while ensuring adherence to, and compliance with, established company quality policies, practices, SOPs and cGMPs
Issues, tracks and closes investigations and CAPAs
Assists in investigations, root cause analysis, Corrective and Preventive Action (CAPA) activities in accordance with the companys Quality System; Tracks and trends appropriate metrics for open CAPAs, planned deviations, product complaints, etc.
Reports monthly metrics pertaining to investigations and CAPA to Quality department head and other appropriate company personnel
Assists with SOP revision and participates in inspections, as needed
Assists in other areas of QA and may cross train across department, as needed
Associates degree or equivalent college (Bachelors degree preferred) AND minimum 3 years experience in the pharmaceutical or biotechnology industry OR combination of education and related quality and/or compliance experience in the pharmaceutical or biotechnology industry.
Experience working with Investigations, Root Cause Analysis, CAPAs and/or Customer Complaints
Current working knowledge of cGMPs in the pharmaceutical industry
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
System One, and its subsidiaries including Joul, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services 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 full-time 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.