Nesco Resource is partnering with an international Pharmaceutical manufacturer in their search for a Vendor QA specialist. This role would be based out of their Central Islip location with 25% travel around the U.S. and Canada. If you are a QA specialist who is looking to expand your horizons and love to travel, apply now!
Third-Party QA Specialist
Responsibilities
- Accountable for the oversight of work plan and deliverables of third-party QA groups.
- Accountable for special projects and initiatives as directed.
- Facilitating and delivering systems, processes, and operations to manage drug, biologic, combination, or device products produced by third-party external manufacturing and packaging partners.
- Ensure ongoing compliance with quality and industry regulatory requirements.
- This role will be part of the QA Team whose role is to ensure our patients receive medicine of the highest quality.
- Set work plans and schedules to align with business priorities.
- Direct work on an individual or group basis, as required.
- Work with CMO departments regarding Quality issues and activities and to channel communications and escalations on both a global and regional basis for third-party QA.
- Implement systems and processes that deliver compliant, safe, and effective products.
- Identify and lead projects for continuous improvements and efficiencies.
- Implement Quality KPIs that measure, analyze, and continuously improve the delivery of compliant, safe, and effective products.
- Participate in Quality Audits and Management Review.
- Evaluate Standards and Regulations against local SOPs to identify and eliminate gaps in policies.
- Conduct troubleshooting or investigation activities in a group setting.
- Ensure that tools are provided, and concerns are escalated, as appropriate.
- Ensure compliance to all data integrity and cGMP practices, procedures, and expectations.
- Ensure compliance and monitor the quality management systems of contract manufacturing facilities.
- Ensure continuous improvement in contract manufacturing facilities by conducting periodic audits to ensure compliance with respect to CFR, cGMP, ICH standards as applicable.
- Ensure the quality of the product before the release of batches for distribution.
- Participate in technology transfer activities at contract manufacturing facilities.
- 5 years of relevant experience in a pharmaceutical-regulated industry in Quality Assurance and Compliance.
- 2 years' experience in quality management in a pharmaceutical company.
- 3 years relevant experience directing work in a group setting and cGMP environment of a manufacturing facility.
- BS or BA in Chemistry or related technical/physical science from an accredited college/university is required. A master's degree in a field to study relevant to the position is preferred.
- Solid project management skills and experience are required.
- Must have working knowledge of cGMPs, CFR (210/211/ 820/4), ICH and applicable international regulations/guidelines.
- Experience with Quality Systems such as electronic deviation and documentation management systems, SAP, and serialization as well as conducting Quality audits.
- Experience with external pharmaceutical manufacturing, packaging, testing and devices is desired.
- Experience with sterile products and devices desired.
- Proficiently communicate and understand (read and write) scientific / regulatory based 'work” in English.
- Strong computer skills including Microsoft Office Tools, Track Wise, Oracle and SAP.
- Ability to understand and analyze complex data sets.
- Strong desire towards continuous improvement.
- Bilingual in the Spanish language (speaking, writing, interoperating and translation) is preferred.
- Have excellent organization, learning and teaching skills required to work in teams.
- Able to wear appropriate personal protective equipment at all times, when required.
- Sitting at a desk and/or working at a computer or other "screen” 75% or greater of an 8-hour period.
PRO038
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.