Supply Chain Specialist 2, Compliance

Job Description

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.

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, 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.

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

• A high school diploma or equivalent and 6 years of relevant work experience
• A bachelor’s degree in Supply Chain, Engineering, Information Science, Data Management, or Life Science related field and 2+ years relevant work experience

Preferred Requirements

• A bachelor’s degree 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

Benefits

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.

Physical Requirements

• Will work in environments which may necessitate respiratory protection
• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program
• Will work in environments operating a motor vehicle or Powered Industrial Truck
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time
• Ability to sit for prolonged periods of time
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers
• Ability to operate machinery and/or power tools
• Ability to conduct work that includes moving objects up to 33 lbs.
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions
• Will work in warm/cold environments
• Will work in outdoor elements such as precipitation and wind
• Will work in small and/or enclosed spaces
• Will work in heights greater than 4 feet