3D Systems, Inc. Quality Product Release Specialist in Littleton, Colorado
Quality Product Release Specialist
In this role you will perform timely and accurate quality review of device history records to ensure batch disposition and release. This person will serve as reviewer and approver for products and documentation in a medical device manufacturing environment, ensuring compliance to customer and regulatory requirements. A successful candidate will be able to manage multiple tasks and adjust priorities based on production volume. This position requires the ability to interact with multiple functional areas quickly and effectively resolve batch record documentation related issues, ensuring delivery schedules are maintained.
Principal Duties and Responsibilities:
Review batch documentation for accuracy and completeness according to cGMP’s to ensure timely release of batches.
Adhere to internal/external guidelines, specifications and regulatory requirements while reviewing batch documentation.
Ensure all GMP’s, Work Procedures and SOP’s are followed.
Identify exceptions and report exceptions to production.
Ensures nonconformities/deviations are initiated for any batch record review related events.
Communicate nonconformities/deviations to appropriate department for investigation.
Resolve documentation discrepancies and issues with manufacturing/operations personnel in a timely manner to allow for product release.
Addresses deficiencies and ensures timely completion of all follow-up actions for resolution to all batch review issues according to GMP standards.
Responsible for final batch disposition, certificate of compliance and/or analysis, based on review of all associated documentation.
Assist in resolving quality issues related to batch review.
Proactively work to ensure schedules are maintained.
Build quality into all aspect of the material release process by maintaining compliance to all quality requirements
Expected Areas of Competence
High attention to detail
Excellent verbal and written communication skills
Proficient in Microsoft Office
Proficient in Microsoft Outlook
Experience in manufacturing is preferred
Knowledge of good documentation practices is preferred
High School Diploma or GED required; Associate Degree or vocational tech certificate, preferred
0 - 2 years of relevant work experience
Compensation and Benefits
Salary Range: $14.81 - $20.72 (salary to be determined by the education, experience, knowledge, skills, and abilities of the candidate, and alignmentwith market data).
In addition to a salary, this position is eligible for an annual bonus based upon company performance.
3D Systems offers a comprehensive benefit package including medical, dental and vision coverage, company-paid short-term and long-term disability insurance, and company-paid basic life insurance. Sick Leave, Flex (Vacation) Time, Parental Leave, and paid time off for recognized holidays. 3D Systems also provides a 401(k) Retirement Savings Plan option with a company match.
Title: Quality Product Release Specialist
Requisition ID: 21000039