Senior Quality Specialist

Description:

The Senior Quality Specialist is part of the Quality Assurance Department at Ridgefield,

NJ. This role is responsible through participation in the Supplier Management Team,

track and manage Supplier Change Notice (Third Party Change Notification Process),

maintaining the supplier corrective action program, and interaction with the individual

supplier/vendor. The responsibilities include the following:

" 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.

Requirements:

" Bachelor's degree in science disciplines.
" Minimum two years of pharmaceutical industry experience.
" Extensive Supplier Management experience,
" Strong understanding in FDA CFR Parts 11, 210, 211, and 820, ISO 13485, 9001 and/or other applicable regulations.
" Strong knowledge of quality and compliance in a regulated GxP/QMS environment.
" Handling ASL and QTAs, usage of Athena, QMS System
" Very good communicator, writing and organizational skills.
" Ability to multi-task.
" Adaptable to change.
" Ability to work in a team as well and individually.
" Ability to draw on past experiences to influence future outcomes.
" Ability to research information for problem resolution to projects.