Quality Assurance Engineering Specialist (2nd shift)

Hours are Monday to Friday 3:00PM - 11:30PM

$86,000-96,000/yr

Overview

Quality Assurance Engineering Specialist will provide Quality Engineering oversight and support for the development and operations of a commercial scale cGMP cell therapy manufacturing and laboratory facility along with associated software applications. This Quality Assurance Engineering Specialist will be responsible for supporting the design, installation and evaluation of GMP equipment, system utilities, components, products and computer systems while ensuring they are fully operational, effective and free from defects during the entire system lifecycle. Further support the formulation of quality policies, procedures as well as conducting training on quality concepts/tools. In addition, the Quality Quality Assurance Engineering Specialist will support audit and submission activities for regulatory compliance.

Specific Responsibilities

• Identifying risk, developing mitigation strategies, alternative solutions, resolving issues, in collaboration with cross functional groups such as Manufacturing, Quality Control, IT, Supply Chain, Engineering and Validation.
• Creating and maintaining company documentation, such as quality manuals, Standard Operating Procedures and Work Instructions.
• Applying good manufacturing practice and observing that it is being adhered
• Represent Quality on cross-functional teams to complete projects, address quality issues and implement quality system improvements.
• Provide technical guidance to cross-functional teams on quality engineering activities that integrate into multiple product lines and/or systems with significant complexity including root cause analysis investigations, addressing purchased component quality issues, complaint product evaluations, development and implementation of corrective actions, initiation and approval of product/process changes and disposition of discrepant material.

Education and Qualifications

• BA/BS degree in scientific or engineering discipline
• 3+ years of bio pharmaceutical industry experience in a technical or supporting technical role
• 2+ years leading or supporting GxP System implementation and validation
• 2+ years of experience in a Quality role is highly desirable
• Demonstrable experience creating and utilizing inspection/testing
• Strong experience developing and executing protocols for single-use process systems, lab systems and software applications in a cGMP environment
• Demonstrable experience creating and maintaining policies, processes and procedures for a new cGMP facility
• Demonstrable experience utilizing risk-based assessments and setting up lifecycle verification programs for manufacturing and laboratory systems.
• Ability to effectively communicate with management and project team members
• Demonstrated ability to collaborate and influence across organization to gain support and commitment for team goals; effective management of groups of professionals to achieve desired results
• Strong professional interpersonal and communications skills, both verbal and written to provide clear direction for the business, vendors, internal stakeholders
• Ability to meet deadlines and multi-task efficiently
• Must be comfortable in a fast-paced environment with limited direction and changing priorities
• Experience identifying changes, driving improvements, and streamlining processes required
• Proficient with the Microsoft Office Suite, Word, Excel, PowerPoint and Project

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

• Physical Demands and Activities Required:Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
• Must meet requirements for and be able to wear a half-face respirator.
• Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps.
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions
• Must be able to lift and carry objects weighing 45 pounds.

• Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline

• Work Environment: This position will work in both an office and a manufacturing lab setting
• When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
• Able to work in cleanroom with biohazards, human blood components, and chemicals.
• Potential exposure to noise and equipment hazards and strong odors.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.