Production Change Control Manager at NEPHRON SC, LLC

West Columbia, South Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

16 Apr, 26

Salary

0.0

Posted On

16 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, cGMPs, FDA Regulations, Change Control, Technical Writing, Analytical Skills, Problem Solving, Interpersonal Skills, Data Integrity, Collaboration, Documentation Standards, Training, Process Improvement, Manufacturing, Validation, Regulatory Compliance

Industry

Pharmaceutical Manufacturing

Description

Description Job Purpose: The Production Change Control Manager is responsible for overseeing and managing change control activities related to manufacturing operations, including production processes, equipment, facilities, materials, and associated documentation. This role ensures compliance with FDA regulations, cGMPs, and internal quality systems by evaluating the impact of proposed changes, implementing appropriate controls, and maintaining product quality, safety, and regulatory compliance. The Production Change Control Manager serves as a subject matter expert (SME) for change control within manufacturing and provides guidance to cross-functional teams to ensure changes are properly assessed, documented, approved, and implemented Essential Duties and Responsibilities: Manage and oversee production-related change control activities in accordance with FDA regulations, cGMPs, and company quality policies. Facilitate the review, coordination, and approval of change records related to manufacturing processes, equipment, facilities, materials, utilities, and production systems. Evaluate and facilitate review of proposed production changes to assess potential impact on product quality, process performance, validation status, regulatory filings, and compliance. Ensure all changes are thoroughly documented, including change requests, impact assessments, risk assessments, implementation plans, and effectiveness checks. Ensure change controls are appropriately linked to validation, qualification, calibration, maintenance, and training requirements, as applicable. Review controlled documents (SOPs, batch records, work instructions, forms, and labels) to ensure accuracy, completeness, and compliance with approved production changes. Participate in Change Review Board (CRB) meetings, including presentation of production change metrics, trends, and KPIs. Present quarterly change control trends and performance metrics at Quality Management Review (QMR) meetings. Investigate and resolve issues or delays related to change control approvals by collaborating with cross-functional stakeholders. Monitor the effectiveness of production change implementations and identify opportunities for process improvement. Ensure data integrity, traceability, and accuracy of all change control records. Support manufacturing initiatives, campaigns, and special projects requiring change control oversight. Communicate quality-related risks, issues, or noncompliance related to production changes to Quality Management or designee. Participate in continuous improvement efforts to enhance the efficiency and effectiveness of production change control processes. Perform other duties as assigned or required to support manufacturing and quality objectives. Supplemental Functions: Support and participate in customer, internal, and regulatory audits and inspections, specifically related to production change control. Educate and train manufacturing and support personnel on production change control procedures, documentation standards, and best practices. Conduct system access and change control training for new production and support employees. Periodically review production change control activities and metrics to identify trends, risks, and improvement opportunities. Job Specifications and Qualifications Knowledge & Skills: Strong technical background with solid knowledge of Quality Assurance, cGMPs, FDA regulations, and QMS-based change control systems. Hands-on experience managing production change controls within electronic Quality Management Systems (eQMS). Excellent written and verbal communication skills with strong interpersonal abilities. Strong analytical, critical-thinking, and problem-solving skills, with high attention to detail and data integrity. Ability to manage multiple priorities, meet deadlines, and perform effectively in a fast-paced manufacturing environment. Ability to work independently and collaboratively across cross-functional teams. Proficient in technical writing and use of Microsoft Word, Excel, and Adobe Acrobat. Demonstrates professionalism, integrity, and discretion in handling confidential quality and regulatory information. Education/Experience: · Bachelor’s degree in Engineering, Life Sciences, Chemistry, Biology, or a related technical discipline required. · Advanced degree or Quality/Regulatory certification (e.g., ASQ, CQE, CQA) preferred. · 5+years of experience in a regulated manufacturing environment (pharmaceutical, biotech, medical device, or related industry). · 3+ years of hands-on experience managing change control within a QMS or electronic QMS (eQMS). · Demonstrated experience evaluating changes to manufacturing processes, equipment, facilities, utilities, and materials. · Working knowledge of cGMP, FDA regulations, and quality systems governing production operations. · Experience supporting regulatory inspections, customer audits, and internal audits. · Proven ability to collaborate with Manufacturing, Engineering, Validation, Maintenance, and Quality teams. · Experience leading or participating in Change Review Boards (CRB) and presenting change control metrics or KPIs preferred. Working Conditions / Physical Requirements: This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility. Willingness to change direction and focus to meet shifting organizational and business demands. Individual may require to wear specified protective equipment if necessary Hours of work: Monday thru Friday on 8 hours shift, or as needed based on company demand.

Responsibilities

The Production Change Control Manager oversees change control activities related to manufacturing operations, ensuring compliance with FDA regulations and maintaining product quality. They evaluate proposed changes, implement controls, and guide cross-functional teams in assessing and documenting changes.