Noven Pharmaceuticals, Inc - Miami, FL
Sr Supplier Specialist (Biotech)
Sr. Supplier Specialist shares responsibilities between the Stability Program and the Supplier Quality Group. They are responsible for executing the operations of the Supplier Quality Management System from the maintaining and assessing supplier metrics, performing Supplier Corrective Action (SCAR) Investigations, performing of supplier audits, leading of Supplier Management Team (SMT) discussions, generating Supplier Quality reports for APQR and identifying process improvement strategies. This is inclusive of, but is not limited to raw material suppliers, packaging component suppliers, distributors, laboratories, service providers, and contract manufacturers. Additional responsibility for the Supplier Quality Area, they will be the responsible for the disposition of raw materials and packaging components that are deemed rejected, returned to vendor or discard as it directly impacts the SCAR process. They will oversee every aspect of the Stability Program supporting commercial manufacturing, validation, post approval changes and new product introduction from authoring of the Master Stability Protocols through generation of Stability Reports (Regulatory Annuals, APQR, Post-Approval Reports, etc.).
The candidate must have strong interpersonal and leadership skills to facilitate cross functional teams in the prompt resolution of investigation issues (Stability OOS, Discrepant Supplier Materials, etc). Good written and communication skills are important in communicating with internal customers and external suppliers. Technical Writing Skills in English are also required for the creation of procedures, investigations, reports, and other documentation. Statistical knowledge and applications to Stability Program is critical to analyzing stability data and the confirmation of product expiry and the effective of established Internal Limits/OOT.
A candidate should exercise initiative, good judgment and leadership in resolving emergencies/excursions associated to the stability chambers. Attention to detail in the creation and review of all documentation is a must.
Must be highly organized and able to work multiple projects simultaneously and be able to exercise proper judgment and decision making in evaluating data from both the Supplier Quality and Stability Programs. Good planning and organizational skills are required to schedule sample pulling at appropriate intervals while balancing other tasks associated to the role.
A strong background in software such as TrackWise, MasterControl, JDE, MES, LabWare LIMS and statistical software is a plus. Excellent computer skills in the MS Office Suite of products (Excel, Word, Access and PowerPoint) are needed.
Education / Experience:
Minimum of Bachelor's Degree in Chemistry or other scientific discipline. Four or more years proven professional experience with increase responsibility within the Quality/Technical Services and/or Manufacturing areas in the pharmaceutical/medical device industry is required. Experience in administration of a Stability Program and/or background in Supplier Auditing, being a Certified Quality Auditor (CQA) through ASQ is preferred.
Judgment / Decision Making:
Duties are performed within framework of departmental guidelines, requiring decision making and original thinking with minimal supervision. Candidate must demonstrate a strong sense of responsibility and ownership. Must also have the ability to analyze and assess impact of a finding to product quality, using risk based approach.
Primary work space is an office environment. Availability to work off hours as needed to support stability chamber continuous operation by coordinating with appropriate departments on any repairs. Requires routine visits to
Stability Chambers with conditions up to 30°C/75% RH conditions. There is occasional exposure to reach-in Stability Chambers with conditions up to 40°C/75% RH. This job works with Class II Controlled Substances.
Occasional domestic and international travel might be required to perform Supplier Audits.
Majority of time spent working at a desk. Visual acuity and manual dexterity required to operate computer and proofread documents. Occasionally may be required to lift objects weighing up to 20 pounds. Require walking to other buildings to participate in meetings. Available to work off-hours in meeting project deadlines, presence might be required sometimes as well as remote work.