Supply Chain Specialist 1, Compliance

Supply Chain Specialist 1, Compliance

The Supply Chain Specialist 1, Compliance is responsible for supporting actions, processes, and audit readiness. 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. The SC Specialist 1, Compliance assists with initiation and investigation of internal and external exceptions impacting Supply Chain, supporting the establishment, and implementation of comprehensive corrective and preventative actions (CAPAs) 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.

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 and coordinates supplier change notification (SCN) activities, logging the SCN in the tracker, coordinating review with subject matter expert (SME), while opening and owning change management records, as needed

Participates in optimization projects to ensure continuous process improvements and development for the organization and / or client

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 improvement, and continuous improvement (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

Coordinates 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

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 manage with multiple priorities

Advanced Excel skills

Basic Requirements

High School or GED with 4 years of relevant work experience; OR

Bachelor's degree 0-1 years of experience

Preferred Requirements

Bachelor's with 2 years of relevant work experience

Experience with FDA Audits or similar organization management

Experience with GMP regulations

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