Supply Chain Specialist 2, Compliance

Position Overview

The Supply Chain Compliance Specialist 2, is responsible for actions, processes, and audit readiness at FDBN. This role supports all Supply Chain operations, procedures, systems, processes, and GXP related matters in accordance with the GXP requirements defined in the Pharmaceutical Quality System. Support includes initiation and investigation of internal and external exceptions impacting Supply Chain, supporting the establishment, and implementation of comprehensive corrective and preventative actions to prevent recurrence and drive improvements, coordinating vendor change notifications, raw material enrollment and supplier complaints. This role coordinates internal and external changes impacting Supply Chain planning, master data, warehouse and logistics, and customer requirements.

Job Description

What You'll Do

• Creates, revises, and maintains current Standard Operating Procedures (SOPs), work instructions, training compliance standards, and applicable documentation to support the Supply Chain organization
• Supports optimization projects to ensure continuous process improvements and development for the organization and/or client
• Supports the analysis, revision, and resolution for master data issues, including inventory, SAP processes, cycle counting and other processes within the Supply Chain function
• Coordinates and leads change management records for raw material enrollment, vendor change notifications and supplier complaints
• Performs, initiates, and supports change management records, investigations, CAPAs, 3C and CI activities for Drug Substance and Drug Product
• Works in multiple functions and participates in projects/initiatives for Supply Chain support; including SAP, Warehouse, Shipping/Logistics, Master Data, Weigh and Dispense, and Raw Material Sampling
• Leads investigations updates SOPs, implements CAPAs, performs investigations, as needed
• Collaborates with cross functional teams and subject matter experts (SMEs) for assessment and necessary actions to meet schedules, compliance actions, or project initiatives
• Plans, facilitates, and coordinates with SMEs, Quality, Manufacturing, Process Science, and Customers to ensure changes are implemented compliantly within defined timelines and documented in the appropriate quality system.
• Ensures data integrity and compliance for operations and audit readiness
• Performs other duties as assigned

Knowledge & Skills

• Effective communication, both written and oral
• Results-oriented and strong interpersonal skills
• Effective problem-solving skills
• Ability to effectively present information to others
• Ability to work cross-functionally with a diverse team
• Ability to prioritize with multiple priorities

Basic Requirements

• High School or GED and 6 years of relevant work experience OR
• BS/BA degree in Supply Chain, Engineering, Information Science, Data Management, or Life Science related field and 2 + years relevant work experience

Preferred Requirements

• BA plus 3+ years of relevant work experience
• SAP S4/HANA or other SAP ERP system experience
• GMP regulation experience
• Audits with FDA or similar organization management
• Advanced Excel skills

Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading 401(k) savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life-work balance with paid vacation time, sick time, and company holidays. Explore a supportive environment that enriches both your personal and professional growth!

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

PHYSICAL REQUIREMENTS
PHYSICAL DEMANDS
Will work in environment which may necessitate respiratory protection X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. No X Yes
Ability to discern audible cues. X No Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes
WORKING ENVIRONMENT
PHYSICAL DEMANDS
Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes
Ability to stand for prolonged periods of time. No X Yes 60 minutes
Ability to sit for prolonged periods of time. No X Yes 60 minutes
Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. X No Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. X No Yes If yes, 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. X No Yes
ENVIRONMENTAL CONDITIONS
Will work in warm/cold environments X No Yes Range (If yes, specify approximate temperature ranges.)
Will work in outdoor elements such as precipitation and wind. X No Yes
Will work in small and/or enclosed spaces. X No Yes
Will work in heights greater than 4 feet. X No Yes