Pharmaceutical QC Analyst (Process Improvement)

Granules; Chantilly (VA); On-site; USD 70,000 - 98,000; Full time

Job summary

Granules seeks a Pharmaceutical Manufacturing QC Analyst to identify, develop, and implement improvement initiatives for manufacturing processes. You will work with manufacturing, QA/QC, and engineering to drive compliance and right-first-time practices.

You will support drug product manufacturing by ensuring cgmp compliance, adhering to SOPs, and delivering quality and efficiency improvements through hands-on operations and data analysis.

Qualifications

• Bachelor's degree in chemistry or pharmaceutical sciences, or 5+ years directly related experience.
• Knowledge of cGMP and FDA regulatory requirements.
• Hands-on experience in pharmaceutical manufacturing environments.

Responsibilities

• Interpret research, equipment, and operational data.
• Perform, evaluate, and analyze in process testing for quality 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 related documentation.
• Perform in-process audits to ensure compliance with regulations and instructions.
• Train and advise personnel in technical, scientific, and equipment procedures.
• Develop approaches and solve complex problems using new technologies or continuous improvement tools.
• Coordinate activities with suppliers, contractors, clients, or other departments.

Skills

cGMP compliance

FDA regulations

SOPs knowledge

Data analysis

QA/QC collaboration

Problem solving

Education

Bachelor's degree in Chemistry or Pharmaceutical Sciences

Job description

JOB DUTIES OVERVIEW

The Pharmaceutical Manufacturing QC Analyst will be responsible for identifying, developing, and implementing improvement initiatives for manufacturing processes in assigned areas of work. The individual will work closely with manufacturing and quality assurance and quality control and engineering professionals to drive compliance and right first-time practices.

The individual will support manufacturing of drug products, by ensuring product compliance to established current Good Manufacturing Practices (cGMPs), to meet customer requirements and in adherence to Standard Operating Procedures (SOPs). Based on products and strengths, tasks assigned may vary in scope, sequence, complexity, and timing. Prior experience in operations to ideate, develop, execute and deliver products meeting quality standards and efficacy. These projects could primarily be about increasing quality and efficiency.

Responsibilities

• Interpret research, equipment, and operational data.
• Perform, evaluate, and analyze in process testing for quality 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/or revise Master Batch Records and reconciliation, Standard Operating Procedures, forms, and other supporting documentation for products, processes, and operational data.
• Perform in-process audits to ensure compliance of regulations and written instructions and ensuring accuracy of data.
• Train and advise personnel in technical, scientific, and equipment operational procedures
• Develop approach and solve complex problems by utilizing new technologies, or other continuous improvement tools and methodologies
• Coordinate activities with suppliers, contractors, clients, or other departments.
• Advise and train others on the development or use of new technologies.

Requirements

Knowledge & Skills

• Current Good Manufacturing Practices (cGMP) Food and Drug Administration (FDA) and other regulatory requirements
• Awareness of all aspects of Oral solid dosage products and ability to work hands on is essential.
• Standard Operating Procedures for processing equipment, rooms, manufacturing and QC area
• GMP compliance in a regulated work environment
• Manufacturing processes and equipment procedures

Experience & Education

• At least a Bachelor's equivalent in chemistry or pharmaceutical sciences or related field OR Over 5 years of Directly related experience
• Knowledge of Good Manufacturing Practices (cGMP)
• Prior hands on experience within pharmaceutical industry.

Physical Requirements/Working Environment

Physical & mental requirements e.g. lift 50 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

Commitment to long hours of work when necessary to achieve goals

Respirator, lab coat and safety glasses required. Ability to work with potent substances using a glove-box

Disclaimer

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

We believe in fair and transparent pay practices. Actual compensation is determined based on relevant experience, qualifications, skills, and internal equity.