Pharmaceutical QC Analyst (Process Improvement)
About The Position
The Pharmaceutical Manufacturing QC Analyst identifies, develops, and implements improvement initiatives for manufacturing processes in assigned work areas. The role works closely with manufacturing, quality assurance, quality control, and engineering professionals to promote compliance and right-first-time practices. The analyst supports drug-product manufacturing by ensuring compliance with current Good Manufacturing Practices (cGMPs), customer requirements, and Standard Operating Procedures (SOPs). Assigned tasks may vary in scope, sequence, complexity, and timing according to products and strengths. The role draws on operational experience to develop and execute projects, primarily focused on improving quality and efficiency while delivering products that meet quality and efficacy standards. The position requires hands-on work in a regulated pharmaceutical manufacturing environment, including oral solid dosage products. The working environment may involve potent substances and requires use of a respirator, lab coat, safety glasses, and a glove-box. Long hours may be necessary to achieve goals.
Requirements
- At least a bachelor's-equivalent qualification in chemistry, pharmaceutical sciences, or a related field, or more than five years of directly related experience.
- Knowledge of current Good Manufacturing Practices (cGMP), FDA requirements, and other regulatory requirements.
- Knowledge of cGMP in a regulated work environment.
- Awareness of oral solid dosage products and ability to work hands-on with them.
- Knowledge of SOPs for processing equipment, rooms, manufacturing, and QC areas.
- Knowledge of manufacturing processes and equipment procedures.
- Prior hands-on experience within the pharmaceutical industry.
- Ability to work with potent substances using a glove-box.
- Ability to wear a respirator, lab coat, and safety glasses.
- Commitment to work long hours when necessary to achieve goals.
Responsibilities
- Interpret research, equipment, and operational data.
- Perform, evaluate, and analyze in-process testing of raw materials, in-process materials, and finished products.
- Maintain and calibrate production and technical equipment.
- Inspect areas for compliance with sanitation standards.
- Create, review, and revise Master Batch Records and reconciliation documents, SOPs, forms, and other supporting documentation for products, processes, and operational data.
- Perform in-process audits to ensure compliance with regulations and written instructions and to ensure data accuracy.
- Train and advise personnel on technical, scientific, and equipment-operational procedures.
- Develop approaches and solve complex problems using new technologies or continuous improvement tools and methodologies.
- Coordinate activities with suppliers, contractors, clients, or other departments.
- Advise and train others on developing or using new technologies.
- Identify, develop, and implement manufacturing-process improvement initiatives.
- Support drug-product manufacturing in accordance with cGMPs, customer requirements, and SOPs.
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What This Job Offers
Job Type
Full-time
