Product Release Specialist I - 1st Shift

Prestige Brands • Lynchburg, VA

7d

About The Position

The Product Release Specialist I is a Quality Assurance position responsible for the disposition of bulk and finished products through detailed documentation review of batch records, analytical reports, and investigations, as applicable. This position is also responsible for assisting with the oversight and compliance of the stability program. Responsibilities include but are not limited to, completing routine and moderately complex data analysis, and reporting in support of compliance activities related to change controls, supplier quality, auditing, annual product reviews, stability, investigations, and CAPA.

Requirements

• At minimum, an associate degree in science, engineering, business, or related field is preferred, OR equivalent combination of education and at least 5 years of related industry experience.
• Experience in a GMP-regulated industry is required.

Responsibilities

• Perform product release activities using the SAP computerized ERP system.
• Review events, deviations, incidents, planned line tests, rework, etc., associated with batches for cGMP and documentation compliance. Coordinate resolving routine batch documentation issues including associated deviations and event documentation.
• Identify documentation deficiencies and suggest appropriate corrective actions.
• Use considerable judgment skills to troubleshoot and rectify any documentation issues in testing and processing documentation while conforming to company standards for product quality.
• Enforce and comply with company policies and procedures.
• Coordinate and prioritize the daily review and release requirements based on Production Scheduling and daily quality and production events.
• Coordinate and provide status updates on ongoing batch record review and product disposition activities as required and assist the Sr., Product Release Specialist, and Product Release Specialist II in making disposition decisions.
• Provide continuous support in the product disposition and documentation process (batch records, SOPs, etc.) to improve current efficiencies.
• Report metrics for continuous improvements, provide reports, and daily/weekly/monthly KPI reporting as required.
• Provide QA Support for products manufactured internationally as required and provide requested documentation as determined by Regulatory Affairs for international agencies.
• Participate in cGMP training and audit support activities.
• Assist with the stability database maintenance, troubleshooting, configuration, validation, stability study initiation, and assessment of data.
• Assist with tasks to maintain the stability chambers and rooms in a clean and organized manner while also monitoring functional performance.
• Assist with associated tasks for investigations of quality events and advise the Supply Chain of possible release issues.
• Ensure all documentation supporting QA reviews within the Quality Management System programs are complete and appropriate as submitted. Collaborate with task owners to make necessary corrections.
• Support data collection, analysis, review, and reporting for studies initiated by the QA department.
• Maintains cGMP compliance and Good Documentation Practices in preparation and maintenance of documentation for the quality assurance department.
• Comply with cGMP (21CFR Parts 11, 210, and 211).
• Perform other related duties as necessary or required.

Benefits

• The start of a great career working with a diverse group of great people
• The health and safety of every employee... our top priority
• A clean, air-conditioned cGMP environment
• Top notch benefits –paid time off, 401(K) retirement savings with company match, medical, dental and vision, pay annual targeted bonus, competitive pay, life insurance, Flexible spending account, and tuition reimbursement.
• Stability – a record of strong financial performance and part of a growing $1billion company
• A business supporting the Lynchburg community for over 150 years.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree