Product Release Specialist

Job Description

Job Description

Job Title: Product Release Specialist Location: Orangeburg, NY Type: Contract Compensation: $30.00 - $33.00 Work Model: Onsite Hours: 8:00am to 4:30pm Security Clearance: (not specified)

Overview Leave placeholder text here for recruiter to input

Responsibilities

• Review DHRs for assigned products, as appropriate, approve product release through the Enterprise Resource Planning system (ERP).
• Continually work to achieve assigned review time goals as necessary to ensure timely release of product.
• Facilitate resolutions for discrepancies in DHR quality records, work with document preparers to resolve questions, inconsistencies, or missing data issues.
• Provide data and metrics related to accuracy, completeness, and cycle times for records being reviewed.
• Identify opportunities to improve the accuracy, completeness, and cycle time of the quality record process.
• Proactively detect process issues and lead efforts to implement corrective actions for continuous improvement.
• As needed, participate in FDA and other regulatory audits/inspections.
• Provide training and mentoring to junior Product Release Specialists.
• All other duties as assigned by manager.

Requirements

• Bachelor’s degree in Life Sciences.
• Experience: Three to five years of previous related Quality Records/Quality Assurance experience preferred.
• Previous experience within a regulated medical device manufacturing or pharmaceutical environment strongly preferred.
• Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Knowledge of FDA regulations and ISO 13485 preferred.
• Working knowledge of Microsoft Office.
• Experience with large enterprise resource planning (ERP) system.
• Previous regulatory audit experience a plus.
• Technical writing background/experience a plus.
• Strong time management skills required to support changing priority needs daily.
• Strong attention to detail.
• Ability to work under pressure and meet close deadlines.

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.

#M- #LI- Ref: #558-Scientific