QC Sampling Laboratory Implementation Lead

QC Sampling Laboratory Implementation Lead

Location: Northwest Suburbs of Chicago, IL

Work Arrangement: On-site

Contract: 6+ months duration with potential for extensions

Position Summary:

Automated Systems, Inc. (ASI) is seeking an experienced QC Sampling Laboratory Implementation Lead to support the implementation and operational readiness of a new GMP Quality Control (QC) sampling laboratory at our client’s existing GMP production facility in the Northwest Suburbs of Chicago, IL. The laboratory will support Environmental Monitoring (EM), utility monitoring, in-process sampling, and other approved site sampling activities.

In this role, you will develop and execute the laboratory implementation plan, establishing SOPs, work instructions, forms, logbooks, sampling workflows, and chain-of-custody controls to ensure compliant, consistent, and traceable operations. You will coordinate equipment qualification and release, analyst staffing and training requirements, qualification programs, and inventory management processes, including consumables tracking, storage controls, and replenishment systems.

Working closely with QC, Quality Assurance (QA), Manufacturing, Engineering, Validation, Facilities, EHS, Procurement, IT, and external testing laboratories, you will ensure that equipment, procedures, materials, and personnel are ready before go-live. You will also lead operational readiness assessments, address implementation gaps, and coordinate the formal handover to routine operations while ensuring clear roles and responsibilities and adherence to GMP requirements.

Key Responsibilities:

Laboratory Implementation and Operational Readiness

• Lead implementation of the QC Sampling Laboratory from project execution through operational readiness and handover.
• Translate approved User Requirements Specifications into detailed implementation activities, milestones, readiness criteria, and deliverables.
• Coordinate activities across QC, QA, Engineering, Validation, Facilities, Procurement, Manufacturing, EHS, and other applicable functions.
• Establish controlled workflows for equipment staging, sample labeling, sample collection, interim storage, transfer, and sampling schedule coordination.

Sampling Program Implementation

• Establish compliant sampling workflows for Environmental Monitoring, including viable air, non-viable air, surface, and personnel monitoring as applicable to the approved scope.
• Establish utility-monitoring sampling workflows for applicable systems such as Water for Injection, clean steam, and processed compressed air.
• Establish approved in-process sampling workflows and associated handling, storage, and transfer requirements.

Governing SOPs and Quality System Infrastructure

• Author, revise, route, and implement governing SOPs, work instructions, forms, logbooks, and job aids required to operate the sampling function.
• Define requirements for sample collection, labeling, handling, storage, transfer, documentation, and reconciliation.
• Establish procedures for preparation, use, cleaning, storage, calibration status verification, and control of sampling equipment, as applicable.
• Support deviation, change-control, and CAPA activities associated with project implementation.

Equipment Qualification and Validation

• Coordinate lifecycle implementation of sampling and Environmental Monitoring equipment, including user requirements, procurement, receipt, installation, qualification, release, and turnover.
• Provide QC subject-matter expertise for equipment risk assessments and validation strategies.
• Draft, review, manage, or support execution of qualification and validation protocols for laboratory and EM sampling equipment.

Analyst Role Development and Training

• Develop job descriptions for QC Sampling Analysts based on the approved sampling scope, coverage model, and required competencies.
• Design and implement a structured analyst training and qualification program, including curricula, training materials, demonstrations, supervised practice, and documented qualification.
• Establish requirements for initial qualification, independent work authorization, periodic assessment, and requalification where required.

Consumables and Kanban Controls

• Develop master lists for sampling consumables, media, labels, containers, cleaning materials, personal protective equipment, and other routine supplies.
• Partner with users and Procurement to define approved suppliers, item specifications, lead times, minimum stock, reorder quantities, and safety stock.
• Establish Kanban or equivalent visual replenishment controls for critical routine consumables.

Operational Handover and Sustainability

• Confirm required procedures, forms, equipment, training, materials, access controls, and workflows are complete before routine GMP use.
• Coordinate transition from project execution to sustainable routine QC sampling operations.
• Establish post-go-live ownership for procedures, equipment, training, inventory, schedules, performance monitoring, and continuous improvement.
• Prepare a formal project closeout and operational handover package with objective evidence of readiness.

Required Qualifications:

Education

• Bachelor's degree in Microbiology, Biology, Chemistry, Pharmaceutical Sciences, Engineering, or a related scientific discipline.

Experience

• Experience in pharmaceutical or biopharmaceutical Quality Control, microbiology, Environmental Monitoring, aseptic manufacturing, validation, or a related GMP environment.
• Demonstrated experience implementing, transferring, or improving GMP laboratory or sampling operations.
• Experience authoring and implementing controlled procedures and technical documentation.
• Working knowledge of equipment qualification and validation principles, including protocol development, review, execution, deviation management, and final reporting.
• Experience developing technical training and qualification programs.
• Experience leading cross-functional projects involving Quality, Engineering, Validation, Manufacturing, Facilities, and Procurement.

Critical Knowledge and Skills

• Clear technical writing, organization, facilitation, and stakeholder communication

• Change control, deviation, CAPA, and inspection-readiness principles

• Project management, risk management, and cross-functional coordination

• Training curriculum design and practical qualification

• Inventory management, consumables planning, and Kanban systems

• SOP, work-instruction, form, and job-aid development

• GMP sampling, sample handling, chain of custody, and documentation controls

• Environmental Monitoring and aseptic-manufacturing principles

• Equipment qualification and validation lifecycle