QO Primary Packaging Trainer

NEPHRON SC, LLC•West Columbia, SC

16h

About The Position

This role supports the assessment, planning, development, implementation, and evaluation of performance improvement training for Primary Packaging QO staff. The role ensures all initial certifications and recertifications are completed on time and assists with additional duties or responsibilities as needed to support operations.

Requirements

Computer software sills using Microsoft Office programs such as Word, Excel, and PowerPoint required.
Ability to instruct and deliver formal training and workshops in a classroom environment, collect data, prepare status reports and maintain records.
Comprehensive understanding of FDA regulatory frameworks covering both 503B Outsourcing Facility requirements and cGMP operations, including 21 CFR Parts 210/211 and applicable guidance documents.
Strong expertise in sterility assurance, aseptic processing, environmental monitoring, and contamination control strategies within sterile manufacturing, visual inspection, and secondary packaging.
Experience leading FDA inspections, regulatory audits, and customer audits, with strong inspection readiness and response capabilities.
Proven ability to apply quality risk management principles and data-driven decision-making to ensure product quality and patient safety.
Strong leadership, coaching, and organizational development skills, with the ability to build and sustain high-performing Quality teams.
Effective cross-functional collaboration skills, partnering with Manufacturing, Engineering, Technical Services, and Supply Chain.
Experience with change control, deviation investigations, and CAPA systems within a GMP-regulated manufacturing environment.
Prior experience supporting regulatory inspections (FDA, state board of pharmacy, or third-party audits).
Must be detailed oriented and have excellent organizational skills.
Must have excellent communication and technical writing skills.
Ability to drive continuous improvement initiatives while maintaining regulatory compliance and quality standards.
Strong organizational skills with the ability to manage multiple priorities in a fast-paced, regulated environment.
Bachelor’s degree in Engineering, Life Sciences, Pharmacy, Chemistry, or a related scientific/technical discipline required. Strong background in operational excellence, continuous improvement, and performance management.
Demonstrated ability to lead cross-functional teams while maintaining Quality unit independence and regulatory compliance.
At least 5+ years of leadership experience managing Quality teams supporting sterile manufacturing operations.
Hands-on experience with aseptic processing, visual inspection, and secondary packaging.

Responsibilities

Assess and determine training adequacy for Primary Packaging Quality Operations (QO) personnel and management.
Partner cross-functionally with Production, Sterility Assurance, and Environmental Monitoring (EM) to support aseptic compliance, training effectiveness, and operational excellence.
Collaborate cross-functionally with multiple departments to ensure cross-training requirements are identified, met, and sustained.
Ensure onboarding training for new hires is comprehensive, effective, and aligned with all role requirements.
Provide general deviation support, including investigation assistance, root cause analysis, and identification of training-related gaps.
Maintain accurate records of training, retraining, and development plans; communicate identified needs to Quality Operations Management.
Develop, track, and report quality metrics to support the Quality Investigations team in evaluating product-related and secondary packaging quality events.
Partner closely with Quality Management to identify, develop, and execute key training initiatives.
Design and implement organizational training programs, tools, and processes that strengthen and sustain a culture of quality.
Perform Quality Operations job functions in alignment with production demands during periods of limited training activity.
Identify, evaluate, and apply effective program development and training delivery methods to achieve defined learning objectives.
Monitor and routinely assess training quality and effectiveness; provide coaching and feedback to ensure consistent and effective performance.
Identify and implement support systems that reinforce learning and ensure knowledge and skills are effectively applied on the job.
Develop and deploy communication strategies that increase awareness and promote a continuous learning and development culture.
Review production pass-downs in real time to identify trends and potential quality issues, and coordinate appropriate follow-up actions.
Performs other similar duties as required.