Quality Engineer

Job Description

Job Description

Summary/Objective

This position requires an individual who can work within a cGMP environment in collaboration with Quality Assurance, Quality Control, Manufacturing, and Distribution. This includes building expertise, establishing predictable and consistent processes, focusing on business priorities, and accelerating new technologies/processes. The successful candidate must be focused on achieving company goals while sustaining a continuous improvement culture at Epicur Pharma.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Serve as an SME on current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDocP).
• Identify continuous improvement opportunities throughout the organization by routinely studying, prioritizing, and selecting projects that leverage lean manufacturing.
• Develop and utilize tools to identify KPIs to drive continuous improvement and manage weekly/monthly site reporting for Personnel, Safety, Quality, and Manufacturing.
• Facilitate advanced problem solving and analysis of specific improvement opportunities leading to the implementation of effective sustainable solutions.
• Promote the use of data and metrics for identifying improvement opportunities and problem-solving activities.
• Engage with teams to help establish a Continuous Improvement culture and execute advanced problem-solving activities.
• Perform and assist in investigations and lead development of CAPAs.
• Maintain CAPA program for equipment and facilities.
• Assist in development and execution of cleaning validations for relevant manufacturing equipment.
• Develop or collaborate on URS and FDS documentation for relevant projects.
• Support design, development, and delivery of training and project execution.
• Assist in the identification and sharing of best practices across the organization.
• Assist in maintaining all equipment, facilities, and utilities, in the relevant compliant state, during changes and routine review as related to activities. This includes summary reports and/or periodic review that must be documented for each piece of equipment and utility.
• Assist in maintaining equipment database for tracking routine and non-routine maintenance/calibration activities.
• Lead in the development and implementation of new and revised policies/procedures.

• Maintain compliance with company policies, regulatory requirements, quality specifications, safety standards, and sanitation practices.
• Perform quality review of related validation/qualification documentation and processes for other departments.

Required Education and Experience

• Bachelor’s Degree in Biological Science, Chemistry, Biomedical Engineering, or relevant field, preferred
• Minimum 2 years of experience in pharmaceutical/cosmetic manufacturing environment or related field, with degree
• Minimum 4 years of experience in pharmaceutical/cosmetic manufacturing environment or related field, without degree
• Familiar with GMPs, FDA, ICH, OSHA requirements
• Familiar with 21 CFR Part 11, 210, 211, and 820
• Familiar with ICH Q7, Q8, Q9, and Q10
• Experience using Minitab, Excel, and/or relevant applications
• Must have knowledge of basic principles, theories and laws, policies and procedures that pertain to compounding
• Must have strong organizational skills and exceptional attention to detail
• Must exhibit punctuality and low absenteeism
• Able to work independently, as well as part of a team
• Able to sit, stand, squat, kneel, reach and walk for prolonged periods of time
• May need to lift up to twenty-five (25) pounds on occasion

Eligibility Qualifications

• Must be capable of wearing all protective wear as required by Company Safety Policies. This includes, but is not limited to, mask, gloves, gown, hairnet, safety goggles, etc.
• Must be able to work with chemicals used in the preparation of compounds following any special safety precautions as required.

Competencies

• Communication Proficiency
• Decision Making
• Detail Oriented
• Time Management
• Problem Solving/Analysis
• Quality Oriented
• Results Driven
• Technical Capacity

Supervisory Responsibility

This position has supervisory responsibilities of the Quality Assurance Department.

Work Environment

This job operates primarily in an office and a controlled laboratory environment. This position requires the use of standard office equipment, and frequent standing and walking.

Language Skills

Must be able to read, write, speak and understand English fluently and have the ability to read and interpret documents such as operating and maintenance instructions and procedure manuals.

Mathematical Skills

Uses addition, subtraction, multiplication and the division of numbers including decimals and fractions when checking of reports, forms, records and comparable data where interpretation is required involving basic skills knowledge.

Reasoning Ability

Must have the ability to solve practical problems and deal with a variety of concrete variables in situations where substantial standardization exists. Must be able to interpret instructions furnished in written, oral, and diagram or schedule form.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Able to sit and/or stand 8-10 hours or more per day as needed
• May sit, stand, stoop, bend and walk intermittently during the day; may be necessary to work extended hours as needed
• Finger dexterity to operate office equipment required
• Ability to lift up to twenty-five (25) pounds on occasion

Position Type and Expected Hours of Work

This is a full-time position. Because of the nature of the business, work schedules may vary at times.

Travel

No travel is expected for this position.

Disclaimer

The above job description is intended to describe the general nature and level of work being performed by employees assigned to this job. It is not designed to capture or illustrate a comprehensive list of all responsibilities, duties, and skills required of employees assigned to this job.