Business Professional - QA Specialist

The Fountain Group is seeking a QA Specialist for a prominent client. This position is located in Ridgefield, NJ.

Pay: $45/hr

Shift: 100% Onsite, 1st Shift

Duration: 12-months – potential to extend or convert based on performance and budget.

• Responsible for the site's Third-Party Change Notification process (TPCN) which includes logging, triaging, assigning, and determining level of criticality.
• Responsible for tracking TPCN completion and preparing presentations for monthly meetings.
• Assist in reviewing and approving Third Party investigation reports related to Third Party Complaint and Supplier Corrective Action Report (SCAR)
• Additional tasks including updating Standard Operating Procedures (SOPs) and serving as a backup for various Quality Supplier department tasks.
• Assist in maintaining the Supplier Qualification Program for existing and new suppliers/vendors.
• Managed professional relationship with suppliers/vendors to ensure their adherence to quality standards and facilitate environment of continual improvement.
• The Incumbent will ideally have some Project Management experience and will be capable of implementing projects, initiatives, and improvements either as an individual contributor or as part of a team.
• Performance of trending and metric generation will be required as part of this role to ensure compliance and provide confidence that the relevant quality systems are operating in control.
• This position works with Manufacturing Operations, QA Management, Procurement and Suppliers, and Service Providers to provide advice and support in the resolution of compliance-related concerns and initiatives and apply their own professional knowledge to proactively identify areas of risk to compliance GMP's.
• Will be responsible for authoring, reviewing, and approving GMP documentation and may be responsible for developing and delivering training related to supplier management topics.
• Will be assisting in authoring, revising, and maintaining QTA's between vendors and service providers, and liaison with respective parties such as Procurement and Legal.

Bachelor’s degree required
.

2+ years of experience required
.

Pharmaceutical, biotechnology or medical device experience is required
.

Must have supplier/vendor management experience.