Quality Engineer

Stokes Pharmacy•Mount Laurel Township, NJ

34d

About The Position

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.

Requirements

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
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.
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.
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.
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.
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

Responsibilities

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.