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Specification Writer - GMP Supply Chain

Indianapolis, IN $60,000 - $80,000 Permanent

Overview: We are seeking an experienced and detail-oriented Specification Writer to support supply chain operations within a GMP-regulated environment. This role is responsible for translating com...

Quality Control Chemist

Indianapolis 70K - 100K Permanent

Job Responsibilities: Conduct analytical testing of raw materials, in-process samples, and finished pharmaceutical products using techniques such as HPLC, GC, UV-Vis, FTIR, dissolution, an...

Quality Assurance Specialist

Indianapolis 70K - 90K Permanent

Job Responsibilities: Conduct quality assurance audits and inspections of manufacturing processes, facilities, and documentation. Review batch records, SOPs, and quality documen...

Job Responsibilities: • Develop, implement, and maintain training programs for Quality Control personnel, ensuring all team members are proficient in GMP procedures, laboratory techniques, and compa...

Supplier QA Manager

Indianapolis 125K - 150K Permanent

Job Responsibilities: • Ensure that all raw materials, components, and outsourced services meet company, regulatory, and GMP requirements. • Evaluate and approve new and existing suppliers through...

Quality Audit Manager

Indianapolis 125K - 150K Permanent

Job Responsibilities: • Oversee internal audits, client audits, and regulatory inspections covering all GMP operations to ensure full compliance with FDA, EMA, ICH, and client requirements. • Serv...

Quality Assurance Specialist

Indianapolis 75K - 90K Permanent

Job Responsibilities: • Maintain a Quality Assurance presence and verify incoming pharmaceutical shipments and materials against purchase orders, specifications, and receiving documentation in...

Process Improvement Engineer

Fishers 90K - 110K Permanent

Job Responsibilities: Support continuous improvement and capital projects to enhance equipment reliability, process robustness, and overall manufacturing efficiency within a GMP-regulated enviro...

TSMS Engineer

Fishers 80K - 100K Permanent

Job Responsibilities: Select appropriate equipment and single-use components for GMP manufacturing and develop technical documentation such as Tech Transfer Plan, Gap Assessment, Process Flow Di...

Senior TSMS Engineer

Fishers 110K - 125K Permanent

Job Responsibilities: Select appropriate equipment and single-use components for GMP manufacturing and develop technical documentation such as Tech Transfer Plan, Gap Assessment, Process Fl...

Aseptic Manufacturing Specialist

Indianapolis $26.00 - $32.00 p/h Permanent

Responsibilities Follow production and manufacturing procedures. Perform duties in Grade C, D, and controlled non-classified cleanrooms. Conduct aseptic manipulations within Grade A isolator...

Technical Services Supervisor

Indianapolis 120K - 140K Permanent

Job Responsibilities: Lead a team of technical professionals with expertise in formulation, single-use system mixing, filtration, filling, visual inspection, and other manufacturing operations....

Senior Quality Engineer

Fishers 130K - 160K Permanent

Job Responsibilities: Lead the design, implementation, and maintenance of a comprehensive Quality Management System (QMS) aligned with FDA 21 CFR Part 820, ISO 13485, and EU MDR 2017/745. Deve...

Validation Engineer

Indianapolis 80K - 100K Permanent

Job Responsibilities: Execute qualification activities for utilities, equipment, and laboratory systems, including but not limited to clean utilities, autoclaves, washers, fillers, laboratory in...

Senior Aseptic Operator

Indianapolis $30 - $35/HR Permanent

Job Title: Senior Aseptic Operator Job Overview: Our organization, a leader in contract manufacturing for sterile pharmaceuticals and biologics, is seeking a highly skilled Senior Operator...

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