Pharmaceutical QC Analyst (Process Improvement)

Granules Pharmaceuticals; Chantilly (VA); On-site; USD 32,000 - 45,000; Full time

Job summary

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

The analyst will support manufacturing of drug products, ensuring compliance with cGMPs and SOPs, and will vary in scope based on products and strengths.

Qualifications

• Knowledge of cGMP and FDA regulatory requirements.
• Awareness of oral solid dosage products and ability to work hands-on.
• SOPs for processing equipment, rooms, manufacturing and QC areas.
• GMP compliance in a regulated work environment.
• Understanding of manufacturing processes and equipment procedures.

Responsibilities

• Interpret research, equipment, and operational data.
• Perform in-process testing for quality of materials, in-process materials, and finished products.
• Maintain and calibrate production and technical equipment.
• Inspect areas for sanitation compliance.
• Create, review, and revise Master Batch Records, SOPs, forms, and documentation.
• Perform in-process audits to ensure regulatory compliance and data accuracy.
• Train and advise personnel in technical procedures.
• Develop approaches to solve complex problems using new technologies and continuous improvement methods.
• Coordinate activities with suppliers, contractors, clients, or other departments.
• Advise and train others on new technologies.

Skills

cGMP knowledge

FDA regulation awareness

Hands-on pharma manufacturing

Documentation practices

Quality control understanding

Education

Bachelor's degree in chemistry/pharmaceutical sciences or related field

Job description

Job Type

Full-time

Description

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.

Salary Description

$28.00 / hour