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.

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.