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.). 

Responsibilities

• Ensure effective operation of the Supplier Quality Management System & Stability Program.
• Write and review Quality Records (Change Controls, Investigations, CAPA, General Task, etc) as required in support of the Stability & Supplier Quality Programs. This includes the following:
  • Reviewing laboratory and manufacturing data in support of stability failure investigations and participation in the investigation team as deemed appropriate.
  • Investigating discrepant materials with supplier (SCAR Process) and maintaining audit findings and reports as needed in TrackWise.
  • Dispositioning of discrepant materials that Quality will be rejecting/discarding or returning to vendor.
• Writes, revises, reviews, and implements technical documentation including protocols, procedures, forms and reports. This includes issuing Annual Regulatory Reports and Annual Product Review Annexes including appropriate statistical analyses.  Maintain policy and procedure documents to ensure that they are aligned with current GxPs, regulatory requirements and aligned with industry standards.
• Performs annual lot tracking and coordinates with appropriate departments the selection of stability samples.
• Responsible for maintaining the chain of custody and sample lifecycle from study initiation to sample destruction. Pulling Stability Samples as required per procedure and delivering them to the QC Laboratory.
• Enters the new studies in LIMS following the approved Master Stability Protocol. Once received, initiates and places stability samples in the program within established timeframes and in the appropriate storage condition (s) as indicated by the approved Master Stability Protocol. 
• Maintains and monitors documentation of sample pulls, due dates and testing to perform the monthly stability metrics. Responsible for escalation of any late testing to the Stability Manager as appropriate.
• Maintains accurate sample inventory and location of samples using LabWare LIMS. Additionally, maintains control and inventory of controlled substances in the Stability Program.  Performs yearly inventory of controlled samples as appropriate.
• Performs all filing and archiving of stability documentation.
• Provide overall support to Stability program and collaborate with internal stakeholders in Research & Development, Regulatory, Clinical Affairs, and Manufacturing and external partners or regulators.
• Interpretation and implementation of stability guidelines, regulations and regulatory documents to propose a Stability Strategy supporting post approval changes to ensuring the appropriate selection of stability batches for a particular change or in support of commercial manufacturing. This will lead to the generation of Master Stability Protocols using guidelines, regulations and regulatory commitments.
• Audit and review Stability Data from the QC laboratory to ensure results are in compliance and follow the expected product and lot trend. Identify and evaluate product trends using laboratory generated data utilizing the Laboratory Information Management System (LIMS) software and statistical tools to provide early warning of possible market action.
• Ensure that new and existing suppliers meet all applicable compliance requirements. Evaluate suppliers and service providers through audits (on-site, virtual and paper audits) and performance metrics, and develop action plans to mitigate any serious risks.
• Maintain supplier metrics and collaborate with suppliers to develop improvement plans and leading Supplier Management Team Meetings
• Evaluate Quality Agreements for suppliers in conjunction with Noven's Legal Department.
• Develop and performs presentations on Stability/Supplier Quality to present to leadership as required.
• Support QA Product Release team with releasing product as required per management.
• Works under minimal supervision and is expected to independently carry-out non-routine assignments.

Qualifications

Competencies:

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. 

 

Work Environment:

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.

 

Travel:

Occasional domestic and international travel might be required to perform Supplier Audits.

 

Physical Demands:         

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.